MatchMedi
English

선택지 정리됨

Head and neck cancer: 국가별 선택지

이 페이지는 한국어 임상 치료 설명을 새로 쓰지 않습니다. 권위 출처, 진료 전 정리 질문, 임상시험 검색어, 구축 상태를 보여주는 안전한 시작점입니다.

선택지 정리됨고형암최종 확인 2026.06

현재 제공

국가별 선택지를 정리합니다

국가별로 출처가 연결된 선택지와 함께, 진단명·단계·검사 결과·진료과·임상시험 검색어를 정리합니다.

아직 하지 않음

치료 선택을 지시하지 않습니다

이 페이지는 치료 순위, 권장, 적합성 판단을 하지 않습니다.

출처

공신력 있는 출처 기반

모든 선택지는 규제·평가·지침 등 공신력 있는 출처에 연결되며, 새 출처가 검증되면 계속 확장됩니다.

진료 전 정리할 정보

  • 이 항목은 원문 출처와 함께 의료진에게 확인하세요.
  • 이 항목은 원문 출처와 함께 의료진에게 확인하세요.
  • 이 항목은 원문 출처와 함께 의료진에게 확인하세요.
  • 이 항목은 원문 출처와 함께 의료진에게 확인하세요.

임상시험 검색어

Head and neck cancer clinical trial

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

United States

  • cetuximab (Erbitux)[1]FDA-approvedEGFR-targeted therapy; no biomarker test requirement stated in the FDA label excerpt for SCCHN; initial locally/regionally advanced with radiation; first-line recurrent locoregional/metastatic with platinum/fluorouracil; post-platinum recurrent/metastatic monotherapy. · Cetuximab carries label warnings including infusion reactions and cardiopulmonary arrest/sudden death in SCCHN treatment contexts; current label and oncology judgment are required. Confidence/conflicts: high for FDA label indication wording; no conflict identified.
  • concurrent chemoradiation, neoadjuvant chemotherapy plus chemoradiation, adjuvant chemotherapy after chemoradiation, and chemotherapy/immunotherapy contexts[2]Standard option (per NCI PDQ)stages II-IV nonmetastatic; metastatic or locally recurrent disease not amenable to surgery or radiation. · NCI PDQ does not make a patient-specific regimen recommendation in the queue context. Exact regimen choice, sequencing, and toxicity planning are oncology decisions. Confidence/conflicts: high for NCI treatment-option listing; no conflict identified.
  • concurrent chemotherapy with radiation; neoadjuvant chemotherapy followed by concurrent chemoradiation; chemotherapy for unresectable locoregionally recurrent disease[3]Standard option (per NCI PDQ)HPV/p16 status may affect staging; PD-L1 may affect immunotherapy selection in other sources, but NCI PDQ treatment table does not restrict this broad chemo cell by biomarker; stage III-IV disease; unresectable locoregionally recurrent disease. · The NCI page does not specify all regimens in the treatment table. Cisplatin eligibility, hearing, kidney function, neuropathy, performance status, and goals of care affect regimen choice. Confidence/conflicts: high for NCI option listing; no conflict identified.
  • nivolumab (Opdivo)[4]FDA-approvedprogression during platinum-based chemotherapy or recurrence/metastasis after platinum-based chemotherapy. · NCI article is an FDA approval report rather than the current label. Current prescribing information should be checked for exact wording and safety details. Confidence/conflicts: medium-high for FDA approval report; direct current FDA label refresh remains a gap. No conflict identified.
  • nivolumab and hyaluronidase-nvhy (Opdivo Qvantig); nivolumab (Opdivo) reference product[5]FDA-approvedno biomarker requirement stated in the fetched FDA approval notice for the HNSCC formulation scope; across approved adult solid-tumour nivolumab monotherapy, monotherapy maintenance after nivolumab plus ipilimumab, or combination-with-chemotherapy/cabozantinib indications; for HNSCC, discuss only in the context of an approved nivolumab HNSCC indication and current prescribing information. · The FDA notice is a formulation/route approval across existing nivolumab indications; it does not create a new HNSCC line of therapy, guarantee payer coverage, or replace indication-specific prescribing information. Confidence/conflicts: High for FDA formulation approval scope; no conflict identified. HNSCC setting must be tied back to current nivolumab prescribing information before patient-facing use.
  • pembrolizumab (Keytruda) as neoadjuvant treatment, continued after surgery with radiotherapy with or without cisplatin, then as single-agent pembrolizumab[6]FDA-approvedPD-L1 combined positive score (CPS) >=1 by an FDA-approved test; perioperative treatment for resectable locally advanced HNSCC; KEYNOTE-689 enrolled stage III-IVA HNSCC. · FDA approval requires PD-L1 CPS >=1 by an FDA-approved test. It does not imply surgery can be skipped; KEYNOTE-689 included definitive surgery followed by adjuvant therapy. Confidence/conflicts: high for FDA approval wording; no conflict identified.
  • radiation therapy, including external-beam radiation therapy with individualized fields and selected boost approaches[2]Standard option (per NCI PDQ)Epstein-Barr virus (EBV) DNA is discussed by NCI in selected evidence contexts; not a general eligibility claim; stage I; stages II, III, and IV nonmetastatic; selected metastatic or recurrent settings. · NCI describes treatment options and evidence, not individual eligibility. Radiation dose, technique, field margins, and recurrence re-treatment depend on anatomy, prior therapy, clinical expertise, and patient-specific factors. Confidence/conflicts: high for NCI treatment-option listing; no conflict identified.
  • radiation therapy, including standard fractionation, altered fractionation, IMRT, postoperative radiation therapy, and palliative/additional radiation contexts[3]Standard option (per NCI PDQ)HPV/p16 status may affect staging and de-intensification trials; not a drug-selection biomarker in this finding; early-stage definitive treatment; stage III-IV definitive or postoperative treatment; metastatic/recurrent selected contexts. · Radiation planning depends on primary site, nodal extent, previous radiation, dental/swallowing risk, and whether chemotherapy is used concurrently. Confidence/conflicts: high for NCI option listing; no conflict identified.
  • surgery for selected cases[2]Standard option (per NCI PDQ)stages II-IV nonmetastatic option list; highly selected locally recurrent lesions. · Surgery is described for selected contexts and is not implied to be routine or suitable for all nasopharyngeal carcinoma cases. Confidence/conflicts: high for NCI selected-use wording; no conflict identified.
  • surgery, including transoral or other resection approaches, with or without postoperative radiation therapy and chemotherapy[3]Standard option (per NCI PDQ)HPV/p16 status may affect staging and treatment strategy; not a drug-selection biomarker in this finding; stage I-II; stage III-IV; selected metastatic/recurrent settings. · NCI PDQ emphasizes multidisciplinary input and functional outcomes such as speech and swallowing. This is not a site-specific surgical plan. Confidence/conflicts: high for NCI oropharyngeal SCC option listing; no conflict identified. Other HNSCC subsites need separate site-specific PDQ checks.
  • toripalimab-tpzi (Loqtorzi) with cisplatin and gemcitabine; toripalimab-tpzi single agent[7]FDA-approvedPD-1 immunotherapy; no biomarker requirement stated in the FDA approval notice excerpt; first-line metastatic or recurrent locally advanced NPC with cisplatin and gemcitabine; post-platinum recurrent unresectable or metastatic NPC as single agent. · FDA approval notice supports regulatory status, not individual eligibility. Current prescribing information should be checked for full safety, administration, and contraindication details. Confidence/conflicts: high for FDA approval status; no conflict identified.

European Union

  • ESMO-EURACAN clinical practice guideline update covering adjuvant therapy and first-line recurrent/metastatic treatment[8]Standard option (per PubMed / Annals of Oncology)adjuvant therapy and first-line treatment of recurrent/metastatic disease. · The PubMed record confirms the guideline update and scope but does not expose detailed recommendations in the fetched lines. Use as a guideline-source pointer only until the full guideline text is reviewed under license/reuse restrictions. Confidence/conflicts: medium for guideline-source existence and scope; detailed recommendation extraction pending full-text review. No conflict identified.
  • cetuximab (Erbitux)[9]EMA authorisedEGFR expression is referenced in Erbitux product information context; no routine EGFR test requirement stated for SCCHN in the fetched indication lines; locally advanced disease with radiation; recurrent and/or metastatic disease with platinum-based chemotherapy. · Product information says Erbitux must be administered under supervision of a physician experienced in antineoplastic medicines with close infusion monitoring and resuscitation equipment available. Member-state reimbursement varies. Confidence/conflicts: high for EMA product-information indication wording; no conflict identified.
  • cetuximab (Erbitux) with platinum-based chemotherapy[10]HAS reimbursement opinionEGFR-targeted therapy; no biomarker requirement stated in the fetched HAS page; recurrent and/or metastatic squamous-cell carcinoma of the head and neck, in combination with platinum-based chemotherapy. · HAS reimbursement/Transparency Committee wording does not establish current local formulary implementation, hospital access, or individual suitability. The French source should receive human clinical-language review before patient-facing reuse. Confidence/conflicts: High for HAS reimbursement-summary wording; no conflict identified. Translation/human review needed because the source is French. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • cetuximab (Erbitux) with radiotherapy[11]HAS reimbursement opinionEGFR-targeted therapy; no biomarker requirement stated in the fetched HAS English page; locally advanced head and neck squamous-cell cancer with radiotherapy. · The fetched HAS English page is an older Transparency Committee summary and not a current clinical guideline; current French reimbursement conditions and centre-level use should be checked. Confidence/conflicts: Medium-high for the HAS indication summary; current practice/reimbursement detail remains stale and should be refreshed. No conflict identified.
  • nivolumab (Opdivo)[12]Approvedno PD-L1 requirement stated on the fetched HAS page; second-line after failure/progression during or after platinum-based chemotherapy. · The fetched HAS page is French-language source material and needs human review before patient-facing reuse. The page describes France reimbursement/HTA context and does not establish individual eligibility, sequencing after pembrolizumab, or centre access. Confidence/conflicts: Medium-high for original HAS reimbursement/HTA wording; marked for human review because source is French. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • nivolumab (Opdivo)[13]G-BA benefit assessmentno biomarker requirement stated in the fetched G-BA indication text; adult SCCHN with progression during or after platinum-based therapy; early-progression and late-progression groups are treated differently in the G-BA resolution. · The G-BA source is a German HTA/reimbursement decision, not individual eligibility, hospital access, or current negotiated price. The original German source should receive human clinical-language review before patient-facing reuse. Confidence/conflicts: High for German G-BA indication and subgroup benefit framing; no conflict identified. Translation/human review needed because the controlling source is German. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • pembrolizumab (Keytruda) as neoadjuvant monotherapy, continued as adjuvant treatment with radiation therapy with or without concomitant cisplatin, then as monotherapy[14]EMA authorisedPD-L1 combined positive score (CPS) >=1; neoadjuvant and adjuvant perioperative treatment for resectable locally advanced HNSCC. · EMA central authorisation does not determine reimbursement or access in each member state. PD-L1 CPS >=1 is part of the indication. Confidence/conflicts: high for EMA indication wording; no conflict identified. Member-state access remains separate.
  • pembrolizumab (Keytruda) monotherapy[15]ApprovedPD-L1 combined positive score (CPS) >= 1; first-line metastatic or unresectable recurrent HNSCC with PD-L1 CPS >= 1. · G-BA English documents are courtesy translations; only the German version is legally binding. The source is a German benefit-assessment/reimbursement document, not individualized eligibility or centre-level access confirmation. Confidence/conflicts: High for G-BA assessed indication and added-benefit conclusion. No conflict identified.
  • pembrolizumab (Keytruda) monotherapy or pembrolizumab with platinum and 5-fluorouracil chemotherapy[14]EMA authorisedPD-L1 CPS >=1; first-line metastatic or unresectable recurrent HNSCC. · EMA indication requires PD-L1 CPS >=1. The choice between monotherapy and chemoimmunotherapy depends on clinical factors and local access. Confidence/conflicts: high for EMA indication wording; no conflict identified.
  • pembrolizumab (Keytruda) monotherapy or pembrolizumab with platinum and 5-fluorouracil chemotherapy[16]ApprovedPD-L1 CPS >= 1; first-line metastatic or unresectable recurrent head-and-neck squamous cell carcinoma with PD-L1 CPS >= 1. · The fetched HAS page is French-language source material; human review is needed before patient-facing reuse. HAS notes KEYNOTE-048 did not compare pembrolizumab monotherapy directly with pembrolizumab plus chemotherapy for CPS >= 1 and that nasopharyngeal cancer was not included. Confidence/conflicts: Medium-high for original HAS reimbursement wording; marked for human review because source is French. No conflict identified. Primary source not in English. English summary pending human review — confirm exact wording with your care team.
  • pembrolizumab (Keytruda) monotherapy; nivolumab (Opdivo) monotherapy[14]EMA authorisedEMA Keytruda post-platinum entry references PD-L1 TPS threshold; Opdivo entry does not specify a biomarker in the lines fetched; recurrent/metastatic disease progressing on or after platinum-containing/platinum-based therapy. · Keytruda post-platinum indication includes PD-L1 TPS threshold, while Opdivo wording does not in the fetched EMA lines. Reimbursement and test requirements vary by member state. Confidence/conflicts: high for EMA indication wording; no conflict identified, but biomarker requirements differ by product.
  • pembrolizumab (Keytruda) with platinum and 5-fluorouracil chemotherapy[17]ApprovedPD-L1 combined positive score (CPS) >= 1; first-line metastatic or unresectable recurrent HNSCC with PD-L1 CPS >= 1. · This is a German added-benefit decision for the chemotherapy-combination procedure. It should not be read as ranking monotherapy versus combination therapy for an individual patient, and it does not establish local centre availability or toxicity suitability. Confidence/conflicts: High for G-BA assessed indication and added-benefit conclusion. No conflict identified.
  • tislelizumab (Tevimbra) with gemcitabine and cisplatin[18]EMA authorisedno PD-L1 requirement stated for the NPC indication in the fetched EMA product information; first-line adult recurrent NPC not amenable to curative surgery or radiotherapy, or metastatic NPC. · EMA central authorization does not establish reimbursement in Germany, France, or other EU member states. The pivotal trial geography was Asia-only according to EMA's assessment report; local applicability and access should be discussed with an oncology team. Confidence/conflicts: High for EU indication wording and assessment basis; member-state reimbursement unresolved. No conflict identified.
  • toripalimab (Loqtorzi) with cisplatin and gemcitabine[19]EMA authorisedPD-1 immunotherapy; no biomarker requirement stated in the EMA indication lines fetched; first-line recurrent not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma. · EMA central authorisation does not determine reimbursement, hospital access, or timing in each member state. Germany and France HTA/reimbursement status remain separate gaps. Confidence/conflicts: high for EMA central authorisation and indication wording; no conflict identified. Member-state access remains a gap.

United Kingdom

  • cetuximab (Erbitux) with radiotherapy or with platinum-based chemotherapy[20]NICE recommendedEGFR-targeted therapy; no biomarker test requirement stated in the NICE recommendation lines; locally advanced disease with radiotherapy under TA145 restrictions; recurrent or metastatic oral-cavity-origin disease with platinum-based chemotherapy under TA473 restrictions. · NICE TA145 includes performance-status and platinum-chemoradiotherapy-contraindication restrictions. NICE TA473 is limited to cancers starting in the oral cavity and commercial access terms. England-focused NICE appraisal context; devolved-nation access requires separate confirmation. Confidence/conflicts: high for NICE England recommendation wording; no conflict identified, but indication restrictions differ by setting.
  • chemotherapy and chemoradiotherapy[21]Standard option (per NHS)main chemoradiotherapy, neoadjuvant before surgery, adjuvant after surgery, non-surgical, advanced, recurrent, or metastatic settings. · NHS page does not specify drug regimens, eligibility thresholds, or reimbursement conditions. Confidence/conflicts: medium-high for broad NHS category availability; no conflict identified.
  • chemotherapy and chemoradiotherapy[22]Standard option (per NHS)more advanced disease, lymph-node spread, distant spread, recurrence, chemoradiotherapy, and palliative treatment contexts. · Sources do not specify exact UK chemotherapy regimens or reimbursement decisions for newer immunochemotherapy combinations. Confidence/conflicts: high for broad UK treatment-category guidance; no conflict identified.
  • nivolumab (Opdivo)[23]NICE recommendedrecurrent or metastatic SCCHN after platinum-based chemotherapy, with disease progression within 6 months. · NICE notes a commercial access agreement. NICE technology appraisals primarily apply in England; devolved-nation access requires separate confirmation. Confidence/conflicts: high for NICE England recommendation; no conflict identified.
  • nivolumab (Opdivo) or pembrolizumab (Keytruda), as treatments CRUK says may be used for some recurrent or metastatic nasopharyngeal cancer[24]Standard option (per Cancer Research UK)immune checkpoint inhibitor context; no biomarker threshold stated in fetched CRUK lines; some recurrent or metastatic nasopharyngeal cancer. · This is patient-facing charity guidance and does not verify NHS funding, NICE recommendation, MHRA indication, or individual eligibility. NICE/MHRA reimbursement-label refresh remains a gap. Confidence/conflicts: medium for possible UK immunotherapy option as patient guidance; regulator/reimbursement verification pending. No conflict identified. reimbursement not established in this jurisdiction
  • palliative care and symptom-control medicines/support[24]Standard option (per Cancer Research UK)advanced nasopharyngeal cancer, including stage 4B and symptom-control contexts. · Supportive and palliative care is compatible with active cancer treatment; the source does not define individual referral criteria. Confidence/conflicts: high for broad supportive-care guidance; no conflict identified.
  • pembrolizumab (Keytruda) monotherapy[25]NICE recommendedPD-L1 combined positive score (CPS) >=1; untreated metastatic or unresectable recurrent HNSCC. · NICE did not recommend pembrolizumab combination therapy in this appraisal; the recommendation is conditioned on monotherapy use, stopping at 2 years of uninterrupted treatment or earlier progression, and commercial arrangement. NICE technology appraisals primarily apply in England, with devolved-nation access requiring separate confirmation. Confidence/conflicts: high for NICE England recommendation; no conflict identified, but UK-wide access outside England remains a gap.
  • radiotherapy[21]Standard option (per NHS)early cancer treatment, chemoradiotherapy, and advanced symptom-control settings. · NHS guidance is broad and does not specify radiation technique, fields, dose, or patient-selection criteria. Confidence/conflicts: medium-high for broad NHS category availability; no conflict identified.
  • radiotherapy, including external radiotherapy, IMRT, stereotactic radiotherapy, and selected internal radiotherapy contexts[22]Standard option (per NHS)very early-stage; more advanced with chemotherapy; selected recurrence; advanced symptom-relief contexts. · NHS and CRUK pages are patient-facing guidance, not a specific technology appraisal. Technique, dose, and suitability depend on stage, anatomy, prior radiotherapy, and MDT assessment. Confidence/conflicts: high for broad UK treatment-category guidance; no conflict identified.
  • surgery for laryngeal cancer, including removal of all or part of the voice box or laser removal where clinically appropriate[21]Standard option (per NHS)early laryngeal cancer and other stage-dependent settings described broadly by NHS. · NHS guidance is broad patient information, not a national technology appraisal for a specific procedure. Treatment depends on cancer size, type, location, spread, and general health. Confidence/conflicts: medium-high for broad NHS category availability; no conflict identified.
  • surgery, including selected cancer removal or neck dissection for recurrent lymph-node disease[22]Standard option (per NHS)selected recurrence after original treatment, including neck-node recurrence. · Surgery is described as uncommon and selected. This does not imply surgical suitability. Confidence/conflicts: high for broad UK selected-surgery guidance; no conflict identified.
  • toripalimab (Loqtorzi) with cisplatin and gemcitabine[26]Approvedno biomarker requirement stated in the fetched NICE scope; first-line adults with recurrent not amenable to surgery or radiotherapy, or metastatic NPC. · This is a NICE appraisal scope, not final NICE guidance; routine NHS commissioning status should not be inferred until final guidance or managed-access terms are available. Confidence/conflicts: High for NICE in-development scope and marketing-authorisation wording; final NHS recommendation unresolved. No conflict identified.

Japan

  • cetuximab (Erbitux)[27]PMDA-approved (Japan)EGFR-targeted therapy; no biomarker test requirement stated in PMDA approved-drug list entry; head and neck cancer; later dosage entry includes head and neck cancer but the fetched list line does not specify setting beyond the combined indication note. · PMDA list confirms approval-list entries but not the full Japanese label indication, combinations, contraindications, line of therapy, or reimbursement. Confidence/conflicts: medium-high for approval-list status; current Japanese package-insert refresh remains a gap. No conflict identified.
  • cetuximab (Erbitux)[28]PMDA-approved (Japan)EGFR target context implied by cetuximab mechanism; no biomarker selection requirement stated in fetched safety document; head and neck cancer; exact line and combination partners are not specified in the fetched safety-revision document. · This PMDA safety document verifies the Japan indication category and safety-revision context but not detailed current line-of-therapy wording, combination use with radiation or platinum/5-FU, or reimbursement. Confidence/conflicts: Medium for indication confirmation because this is a safety-revision document, not full current label; no conflict identified.
  • cetuximab sarotalocan sodium (Akalux)[27]PMDA-approved (Japan)EGFR-targeted photoimmunotherapy context; PMDA list entry names cetuximab sarotalocan; unresectable locally advanced or recurrent head and neck cancer. · PMDA list entry confirms conditional early approval-list status but does not provide full package-insert conditions, facility requirements, laser-device requirements, or reimbursement detail in the fetched lines. Confidence/conflicts: medium-high for PMDA approval-list status; current Japanese package-insert and device-procedure details remain gaps. No conflict identified.
  • cetuximab sarotalocan sodium (Akalux) with laser irradiation device context[29]PMDA-approved (Japan)EGFR-targeted photoimmunotherapy context; no molecular test requirement stated in fetched excerpt; local treatment for unresectable locally advanced or recurrent head and neck cancer when definitive standard therapy is not feasible or after standard systemic therapy/ineligibility context described in the PMDA review. · Akalux is tied to photoimmunotherapy/laser-irradiation delivery and patient selection requirements; the fetched PMDA review stresses limitations of evidence and preference for standard definitive therapy when feasible. Reimbursement and trained-centre availability were not verified. Confidence/conflicts: High for PMDA indication wording and treatment-position caveat; reimbursement/trained-centre availability remains unresolved. No conflict identified.
  • concurrent chemotherapy with radiotherapy, commonly cisplatin-based in NPC practice but the fetched table does not specify a drug in this line[30]Standard option (per Japan Society for Head and Neck Cancer / Auris Nasus Larynx / HUSCAP)not biomarker-selected in the fetched guideline summary; stage III and IVA nasopharyngeal cancer. · The fetched table provides the recommendation but not full regimen selection or contraindication detail. The full guideline and local insurance/reimbursement rules should be checked for drug choice and implementation. Confidence/conflicts: High for the Japanese guideline-summary recommendation; regimen and reimbursement details unresolved. No conflict identified.
  • induction chemotherapy or adjuvant chemotherapy added to concurrent chemoradiotherapy[30]Standard option (per Japan Society for Head and Neck Cancer / Auris Nasus Larynx / HUSCAP)not biomarker-selected in the fetched guideline summary; stage III and IVA NPC around concurrent chemoradiotherapy. · The recommendation is weak, not a universal mandate. The fetched summary does not specify which induction/adjuvant regimen to use or which risk groups should receive it. Confidence/conflicts: High for the weak recommendation as stated; patient-selection details unresolved. No conflict identified.
  • intensity-modulated radiation therapy (IMRT)[30]Standard option (per Japan Society for Head and Neck Cancer / Auris Nasus Larynx / HUSCAP)not biomarker-selected in the fetched guideline summary; treatment of nasopharyngeal cancer; exact stage and technique details should be taken from the full Japanese guideline/radiation-planning documents. · This is an English summary of Japanese guidelines, not a reimbursement schedule or hospital-capacity map. It does not establish access to IMRT at a specific centre. Confidence/conflicts: High for the guideline-summary recommendation; access/reimbursement unresolved. No conflict identified.
  • nivolumab (Opdivo)[27]PMDA-approved (Japan)relapse or distant metastasis of head and neck cancer. · PMDA list entry confirms approval-list presence but does not provide full current Japanese label wording, prior-therapy requirements, dosing, or reimbursement detail in the fetched lines. Confidence/conflicts: medium-high for approval-list status; current Japanese package-insert refresh remains a gap. No conflict identified.
  • nivolumab (Opdivo)[31]PMDA-approved (Japan)no biomarker requirement stated in the fetched PMDA review-report excerpt; recurrent or distant metastatic head and neck cancer; the report context is Opdivo review for this head-and-neck indication. · This fetched PMDA source supports review/safety and indication context but is not a current full electronic package insert. Exact current Japanese label wording, reimbursement, and sequencing after pembrolizumab were not verified in this batch. Confidence/conflicts: Medium-high for PMDA review-report support; full current label/reimbursement remains a gap. No conflict identified.
  • pembrolizumab (Keytruda)[27]PMDA-approved (Japan)PMDA approved-drug list entry does not specify biomarker in the fetched lines; recurrent or metastatic head and neck cancer. · PMDA list entry confirms approval-list presence but does not provide full Japanese package-insert wording, biomarker requirements, dosing, reimbursement, or current label restrictions in the fetched lines. Confidence/conflicts: medium-high for approval-list status; current Japanese package-insert refresh remains a gap. No conflict identified.
  • pembrolizumab (Keytruda)[32]PMDA-approved (Japan)PD-L1 CPS >= 1 for first-line pembrolizumab monotherapy or combination; TPS >= 50 for the post-platinum recurrent/metastatic monotherapy wording in the fetched PMDA English product-information excerpt; first-line metastatic or unresectable recurrent HNSCC with PD-L1 CPS >= 1; post-platinum recurrent or metastatic HNSCC with PD-L1 TPS >= 50 in the fetched English product-information excerpt. · PMDA English documents are reference material and may not be the latest Japanese electronic package insert. Japanese original labeling, reimbursement, companion diagnostic requirements, and current dosing should be checked before patient-facing reuse. Confidence/conflicts: Medium-high for PMDA-hosted English review/product-information context; current Japanese e-label and reimbursement remain gaps. No conflict identified.
  • pilocarpine hydrochloride (Pacif Capsules)[27]Standard option (per Pharmaceuticals and Medical Devices Agency)dry-mouth symptoms after radiotherapy for head and neck cancer. · Supportive-care listing does not establish suitability for an individual or address contraindications, adverse effects, or alternatives. Confidence/conflicts: medium for approval-list status; current package-insert refresh remains a gap. No conflict identified.

Korea

Australia

  • IMRT/EBRT with contouring resources plus supportive referrals[34]Standard option (per eviQ / Cancer Institute NSW)EBV biopsy testing and optional serology noted as prognostic/contextual testing; pre-treatment planning and supportive care around definitive NPC EBRT/chemoradiation. · This entry records protocol-supported care planning, not a drug approval. Local service availability may vary by Australian centre. Confidence/conflicts: High for eviQ supportive-care and planning prompts; no conflict identified.
  • definitive external beam radiotherapy (EBRT) with concurrent chemotherapy[34]Standard option (per eviQ / Cancer Institute NSW)EBV testing on biopsy is noted by eviQ as a prognostic factor; not drug-selection biomarker in this protocol; definitive treatment for nasopharyngeal carcinoma, stage >=T2 any N M0; low-risk cT2N0 may be considered for radiation alone per protocol. · eviQ is a protocol resource and does not by itself establish Medicare/PBS billing, local machine capacity, or individual suitability. It includes pregnancy and prior high-dose same-site radiation cautions/exclusions. Confidence/conflicts: High for eviQ protocol population and treatment category; reimbursement/access unresolved. No conflict identified.

China

  • cetuximab (Erbitux) with platinum-based therapy and fluorouracil[35]NMPA-approved (China)EGFR-targeted therapy; no biomarker requirement stated in the fetched approval announcement; first-line recurrent and/or metastatic SCCHN. · This is a manufacturer press release distributed by PR Newswire citing NMPA approval, not an NMPA product page. It supports a China approval signal for Erbitux but does not establish reimbursement, current label text, hospital access, or individual eligibility. Confidence/conflicts: Medium for China approval because source is manufacturer-distributed rather than regulator-hosted; no conflicting source fetched.
  • toripalimab injection (Tuoyi) monotherapy[36]NMPA: conditionally approvedPD-1 immunotherapy; no biomarker requirement stated in fetched source excerpt; recurrent/metastatic NPC after failure of at least two lines of prior systemic therapy. · The fetched source is manufacturer reporting of NMPA approval, not direct NMPA label text. Current label, conversion from conditional approval if applicable, and reimbursement details require direct Chinese regulator/human review. Confidence/conflicts: medium for approval status because direct NMPA source is pending; high for trial-registry facts. No conflict identified.
  • toripalimab injection (Tuoyi) with cisplatin and gemcitabine[36]NMPA-approved (China)PD-1 immunotherapy; no PD-L1 requirement stated in fetched source excerpt; first-line locally recurrent or metastatic nasopharyngeal carcinoma. · The fetched source is the manufacturer's English release reporting NMPA approval, not a direct NMPA page. Direct NMPA label/approval document and current reimbursement details remain gaps. Confidence/conflicts: medium-high for approval reported by manufacturer and trial-registry context; direct NMPA source remains a gap. No conflict identified.

Russia

Thailand

  • Pembrolizumab (Keytruda) monotherapy[38]ApprovedNot biomarker-selected in fetched Thai NDI English Keytruda indication text; Treatment after progression on or after platinum-containing chemotherapy. · NDI supports label wording but not reimbursement, local availability, prior-platinum timing interpretation, or appropriateness after earlier pembrolizumab exposure. Confidence/conflicts: High for Thai NDI Keytruda indication text; access not established.
  • Pembrolizumab (Keytruda) monotherapy or pembrolizumab plus platinum and 5-fluorouracil chemotherapy[38]ApprovedPD-L1 not stated as required in the fetched Thai NDI English Keytruda indication text for this HNSCC line; PD-L1 testing may still affect treatment discussions under local protocols; First-line treatment of metastatic or unresectable recurrent HNSCC. · NDI supports indication text but not reimbursement, PD-L1 testing policy, chemotherapy partner availability, or individual suitability. Cetuximab and nivolumab Thai HNSCC indications were not verified from acceptable Thai primary sources in this batch. Confidence/conflicts: High for Thai NDI Keytruda indication text; payer/access and biomarker-policy details not established.
  • Pembrolizumab (Keytruda) monotherapy or pembrolizumab plus platinum and 5-fluorouracil chemotherapy[38]ApprovedPD-L1 not stated as required in the fetched Thai NDI English Keytruda indication text for this HNSCC line; PD-L1 testing may still affect treatment discussions under local protocols; First-line treatment of metastatic or unresectable recurrent HNSCC. · NDI supports indication text but not reimbursement, PD-L1 testing policy, chemotherapy partner availability, or individual suitability. Cetuximab and nivolumab Thai HNSCC indications were not verified from acceptable Thai primary sources in this batch. Confidence/conflicts: High for Thai NDI Keytruda indication text; payer/access and biomarker-policy details not established.

Canada

  • IMRT; concurrent chemoradiotherapy with cisplatin; adjuvant platinum/5-fluorouracil chemotherapy[39]Established standard of carenot biomarker-selected in the fetched Alberta guideline; advanced-stage nonmetastatic NPC: T1 N1-3 or T2-4 any N M0. · This is Alberta provincial guideline context, not all-Canada reimbursement or access. Drug substitutions and induction chemotherapy details require local oncology review. Confidence/conflicts: High for Alberta guideline wording; broader Canadian provincial variation unresolved. No conflict identified.
  • clinical-trial participation; palliative radiotherapy; palliative chemotherapy; salvage nasopharyngectomy or re-irradiation/stereotactic treatments in selected local/regional recurrence; palliative care referral[39]Standard option (per Alberta Health Services / CancerControl Alberta)not biomarker-selected in the fetched Alberta guideline; distant metastatic NPC; recurrent or persistent disease after primary treatment. · Options are individualized by performance status and disease extent. This is not a claim that surgery or re-irradiation is feasible for all recurrent cases. Confidence/conflicts: High for Alberta recurrent/metastatic framework; local feasibility and current trial availability unresolved. No conflict identified.
  • nivolumab (Opdivo)[40]CADTH reimbursement recommendationno biomarker requirement stated in the fetched pCODR economic guidance excerpt; recurrent or metastatic SCCHN after at least one line of prior chemotherapy / progression on or after platinum therapy. · This fetched source is an economic guidance report, not the final reimbursement recommendation or a current provincial listing. It notes cetuximab was not routinely available in Canada nor approved in that setting at the time, which affects comparator interpretation. Confidence/conflicts: Medium-high for pCODR net-clinical-benefit and setting text; final/current provincial access remains a gap. No conflict identified.
  • pembrolizumab (Keytruda)[41]CADTH reimbursement recommendationPD-L1 combined positive score (CPS) >= 1; perioperative treatment: neoadjuvant, adjuvant with RT with or without cisplatin, then monotherapy, for resectable locally advanced HNSCC. · CDA-AMC reimbursement recommendations do not guarantee provincial formulary listing, individual eligibility, or centre access. The NCBI summary lists exclusions such as T4b/N3/distant spread and prior treatment except selected resectable recurrences; exact current provincial criteria should be checked. Confidence/conflicts: High for CDA-AMC recommendation scope; provincial access remains unresolved. No conflict identified.
  • pembrolizumab (Keytruda) monotherapy; pembrolizumab (Keytruda) with platinum and fluorouracil chemotherapy[42]Health Canada approvedPD-L1 CPS >= 1 for pembrolizumab monotherapy; no PD-L1 restriction stated for the combination in the fetched CADTH indication text; first-line metastatic or unresectable recurrent HNSCC. · CADTH clinical guidance is not the same as provincial reimbursement implementation. The report notes it is informational and not a substitute for professional medical advice; local funding and biomarker testing access should be checked. Confidence/conflicts: High for Health Canada authorization text as stated by CADTH; provincial access remains unresolved. No conflict identified.
  • tislelizumab (Tevimbra) with gemcitabine and cisplatin, with gemcitabine/platinum wording in pCPA negotiation[43]Approvedno biomarker requirement stated in the fetched CDA-AMC project page; first-line adult recurrent or metastatic NPC. · CDA-AMC recommendations guide public drug plans but do not themselves guarantee provincial/territorial listing. pCPA status is under consideration for negotiation, not concluded. The CDA-AMC project page contains milestone dates and a recommendation type; final local funding should be checked province by province. Confidence/conflicts: Medium-high for national reimbursement-process status; province-level coverage is unresolved. No conflict identified, but CDA-AMC final PDF was not fetchable in this cycle.

출처

  1. U.S. Food and Drug Administration (FDA) — official drug label · official drug label
  2. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  3. National Cancer Institute (NCI) — national cancer agency evidence summary · national cancer agency evidence summary
  4. National Cancer Institute (NCI) — national cancer agency FDA approval report · national cancer agency FDA approval report
  5. U.S. Food and Drug Administration (FDA) — FDA oncology approval notice · FDA oncology approval notice
  6. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  7. U.S. Food and Drug Administration (FDA) — regulator approval notice · regulator approval notice
  8. PubMed / Annals of Oncology — peer-reviewed guideline bibliographic record · peer-reviewed guideline bibliographic record
  9. European Medicines Agency (EMA) — regulator product information · regulator product information
  10. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / reimbursement summary · Transparency Committee drug opinion / reimbursement summary
  11. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / English reimbursement summary · Transparency Committee drug opinion / English reimbursement summary
  12. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / reimbursement summary · Transparency Committee drug opinion / reimbursement summary
  13. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment procedure page / HTA reimbursement record · benefit-assessment procedure page / HTA reimbursement record
  14. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  15. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / HTA reimbursement decision · benefit-assessment resolution / HTA reimbursement decision
  16. Haute Autorite de Sante (HAS) — Transparency Committee drug opinion / reimbursement summary · Transparency Committee drug opinion / reimbursement summary
  17. Gemeinsamer Bundesausschuss (G-BA) — benefit-assessment resolution / HTA reimbursement decision · benefit-assessment resolution / HTA reimbursement decision
  18. European Medicines Agency (EMA) — EPAR / regulator product page · EPAR / regulator product page
  19. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  20. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  21. NHS — national health service patient treatment guidance · national health service patient treatment guidance
  22. NHS — national health service patient treatment guidance · national health service patient treatment guidance
  23. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  24. Cancer Research UK — cancer charity patient treatment guidance · cancer charity patient treatment guidance
  25. National Institute for Health and Care Excellence (NICE) — technology appraisal guidance · technology appraisal guidance
  26. National Institute for Health and Care Excellence (NICE) — final scope for technology appraisal · final scope for technology appraisal
  27. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator approved-drug list · regulator approved-drug list
  28. Pharmaceuticals and Medical Devices Agency (PMDA) / MHLW — package-insert revision/safety information PDF · package-insert revision/safety information PDF
  29. Pharmaceuticals and Medical Devices Agency (PMDA) — review report PDF · review report PDF
  30. Japan Society for Head and Neck Cancer / Auris Nasus Larynx / HUSCAP — clinical practice guideline summary PDF · clinical practice guideline summary PDF
  31. Pharmaceuticals and Medical Devices Agency (PMDA) — review report PDF · review report PDF
  32. Pharmaceuticals and Medical Devices Agency (PMDA) — review report PDF · review report PDF
  33. The Catholic University of Korea research portal / Radiation Oncology Journal — peer-reviewed practice-pattern article record · peer-reviewed practice-pattern article record
  34. eviQ / Cancer Institute NSW — national oncology protocol · national oncology protocol
  35. Merck KGaA via PR Newswire — manufacturer approval announcement citing NMPA · manufacturer approval announcement citing NMPA
  36. Junshi Biosciences — manufacturer regulatory news release · manufacturer regulatory news release
  37. Russian Society of Clinical Oncology (RUSSCO) / RosOncoWeb — professional society clinical recommendations PDF · professional society clinical recommendations PDF
  38. Thai National Drug Information / Thai FDA-MOPH — prescribing information PDF / regulator drug-information repository · prescribing information PDF / regulator drug-information repository
  39. Alberta Health Services / CancerControl Alberta — provincial clinical practice guideline PDF · provincial clinical practice guideline PDF
  40. CADTH / pan-Canadian Oncology Drug Review (pCODR) — initial economic guidance report PDF · initial economic guidance report PDF
  41. Canada's Drug Agency (CDA-AMC) — reimbursement review project page · reimbursement review project page
  42. CADTH / pan-Canadian Oncology Drug Review (pCODR) — final clinical guidance report PDF · final clinical guidance report PDF
  43. Canada's Drug Agency (CDA-AMC) — reimbursement review project page · reimbursement review project page

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.