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선택지 정리됨

신경섬유종증(NF1 / NF2): 국가별 치료 선택지

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

선택지 정리됨희귀·유전 질환최종 확인 2026.06

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

  • selumetinib (Koselugo); mirdametinib (Gomekli)[1]FDA-approvedNF1 clinical/genetic condition; treatment indication in fetched labels is disease/manifestation-defined, not mutation-subtype-defined; Symptomatic, inoperable/not completely resectable NF1-associated plexiform neurofibromas. · Labels and approval notices include age, formulation, cardiac, ocular, dermatologic, gastrointestinal, laboratory, reproductive, and drug-interaction caveats. This entry does not imply use for cutaneous neurofibromas, optic pathway glioma, malignant peripheral nerve sheath tumor, or asymptomatic PN unless separately verified by a source. Confidence/conflicts: High for U.S. approved NF1-PN label status; no source conflict identified.

European Union

  • selumetinib (Koselugo)[2]EMA authorisedNF1 clinical/genetic condition; Symptomatic, inoperable NF1-associated PN; NICE guidance is specifically children aged 3 and over. · EMA authorization does not automatically establish reimbursement in Germany, France, or the UK. NICE HST20 is a UK access/guidance source for the stated pediatric scope and needs updating/expansion verification for adults after the recent EMA adult indication. Confidence/conflicts: High for EU authorization and NICE pediatric guidance; medium for adult UK access because current adult NICE commissioning was not verified this cycle.

Australia

  • selumetinib (Koselugo)[3]ApprovedNF1 clinical/genetic disorder context; no additional biomarker stated; Australian PBS pediatric NF1 plexiform neurofibroma access context. · Manufacturer source is not the PBS Schedule. Current authority criteria, adult access, and exact restriction wording require direct PBS verification. Confidence/conflicts: Medium-high for PBS listing announcement and pediatric access context; live PBS Schedule remains source-pending. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • selumetinib (Koselugo)[4]ApprovedNF1 clinical/genetic disorder context; Australian ARTG-linked label context for adult and pediatric NF1 symptomatic inoperable plexiform neurofibromas. · The healthdirect page is a consumer-facing ARTG-linked medicine page and does not establish PBS subsidy for adults or all listed ages. Monitoring, ocular/cardiac/laboratory/pregnancy caveats require the current PI. Confidence/conflicts: High for Australian ARTG-linked indication; PBS age/funding scope differs and is handled separately. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • selumetinib sulfate (Koselugo)[5]TGA-registered (Australia)NF1 clinical/genetic disorder context; no additional biomarker required by the fetched Australian sources; symptomatic, inoperable or not-completely-resectable plexiform neurofibromas in NF1, as stated by the Australian sources. · The TGA decision summary page documents the original pediatric approval; the fetched current product-information/medicine-information text documents the broader adult-and-pediatric wording. This entry records regulatory/label status only, not PBS subsidy status. Confidence/conflicts: Medium-high. The TGA decision summary and current medicine-information page differ in age-scope wording because the TGA page records the original approval while the medicine-information page reflects current adult/pediatric wording; no direct conflict in the pediatric setting. Availability/reimbursement outside the approving regulator not established.

Thailand

  • selumetinib as hydrogen sulfate (Koselugo)[6]ApprovedNF1; symptomatic, inoperable plexiform neurofibromas as specified by the source; pediatric NF1 patients aged 3 years and above with symptomatic, inoperable plexiform neurofibromas; monotherapy per AstraZeneca Thailand abbreviated PI. · The AstraZeneca Thailand page is manufacturer/HCP promotional-medical content, not the full Thai FDA label; it states the advertisement is the advertiser's responsibility and is intended for healthcare professionals in Thailand. It states the product is a new medicine for hospital use only, pediatric use under age 3 is not established, data older than 18 years are limited, starting treatment in adults is not appropriate in that PI, and monitoring warnings include left-ventricular ejection fraction, ocular toxicity, liver laboratory abnormalities, skin/subcutaneous adverse reactions, vitamin E/bleeding considerations, swallowing/choking risk, and reproductive precautions. This entry does not establish Thai reimbursement or hospital access. Confidence/conflicts: Medium-high: Thai NDI verifies registration numbers and AstraZeneca Thailand verifies the Thailand pediatric NF1-PN indication; no conflict identified, but the full Thai FDA label was not accessible without login and reimbursement remains unresolved.

Canada

  • MRI monitoring, surgery, radiation therapy, cochlear implant, auditory brainstem implant, bevacizumab (Avastin) case-by-case context[7]Standard option (per Tumour Foundation of British Columbia)NF2-related schwannomatosis clinical/genetic condition; British Columbia supportive/specialist pathway for NF2-SWN hearing impairment, vestibular schwannoma monitoring, tumour management, and selected medical therapy discussion. · This is a provincial patient/physician guide, not a regulator label or payer rule. Bevacizumab is not recorded here as an approved NF2 drug; the source itself flags limited Canadian availability and case-by-case evaluation. Confidence/conflicts: Medium-high for BC supportive pathway; drug access for bevacizumab remains uncertain and source itself flags limited availability. No conflict identified.
  • selumetinib (Koselugo)[8]Health Canada approvedNF1 clinical/genetic disorder context; no additional biomarker required by the fetched Canadian product monograph; pediatric patients aged 2 years and above with symptomatic, inoperable plexiform neurofibromas in NF1, as stated by the Canadian product monograph. · The Canadian product monograph states Health Canada has not authorized a geriatric indication and frames the indication as pediatric. This entry records Health Canada label status, not provincial reimbursement or individual eligibility. Confidence/conflicts: High for Canadian pediatric label status; no conflict identified in the fetched Health Canada portal and product monograph.
  • selumetinib (Koselugo)[9]ApprovedNF1 clinical/genetic disorder context; Canadian HTA/reimbursement-review context for pediatric NF1 patients with symptomatic, inoperable plexiform neurofibromas. · CADTH/NCBI review material is a reimbursement and evidence assessment, not a prescribing label. It flags uncertainty in comparative evidence and cost-effectiveness; it does not establish that any individual person can access treatment. Confidence/conflicts: Medium-high for Canadian HTA caveats; no conflict identified with Health Canada approval because HTA/reimbursement review addresses evidence and funding uncertainty rather than market authorization.
  • selumetinib (Koselugo)[10]Health Canada approvedNF1 clinical/genetic disorder context; Canadian national HTA/reimbursement context for pediatric NF1 symptomatic inoperable plexiform neurofibromas. · The fetched PDF is marked draft; final/current CDA-AMC recommendation and provincial implementation must be verified before recording live coverage. CADTH notes uncertainty about how tumour-volume changes correlate with symptoms or function. Confidence/conflicts: Medium because the recommendation PDF is draft and provincial implementation is unverified; Health Canada pediatric label context was previously verified. No conflict identified.

출처

  1. DailyMed / U.S. National Library of Medicine — official drug label · official drug label
  2. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  3. AstraZeneca Australia — manufacturer PBS listing announcement · manufacturer PBS listing announcement
  4. Healthdirect Australia / ARTG-linked medicine page — medicine information / ARTG extract · medicine information / ARTG extract
  5. Therapeutic Goods Administration (TGA) — regulator public assessment/decision summary · regulator public assessment/decision summary
  6. Thai National Drug Information / Thai FDA-MOPH — drug registration listing · drug registration listing
  7. Tumour Foundation of British Columbia — physician guide / patient-advocacy clinical resource · physician guide / patient-advocacy clinical resource
  8. Health Canada Drug and Health Product Portal — regulator product portal · regulator product portal
  9. CADTH via NCBI Bookshelf — pharmacoeconomic/reimbursement review · pharmacoeconomic/reimbursement review
  10. CADTH / Canada's Drug Agency — draft reimbursement recommendation · draft reimbursement recommendation

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.

승인된 치료 너머

임상시험 및 신흥 선택지

환자가 거주하는 국가에서 아직 승인된 표준 치료가 아닌 선택지입니다 — 연구, 임상시험, 허가 외 사용, 담당 종양내과 의사가 먼저 언급하지 않을 수 있는 초기 근거입니다. 각 항목은 근거의 강도에 따라 구분됩니다. 여기에 실린 항목은 조사하고 의료진과 상의할 정보일 뿐, 효과가 입증되었거나 안전하거나 현재 이용 가능하다는 의미가 아닙니다. 임상 세부 내용은 영문이 정본입니다.

임상시험 진행 중

  • bevacizumab; brigatinib; neratinib; retifanlimab; axitinib임상시험 · NCT01207687임상시험Trial only (NCT01207687)United States · NF2-related schwannomatosis / NF2 clinical context; Progressive/symptomatic vestibular schwannoma in NF2-related contexts as defined by trial protocols. · These records do not establish FDA approval for NF2-related schwannomatosis. Trial status may be recruiting, completed, or closed, and eligibility is protocol-specific. Confidence/conflicts: High for U.S. registry status; no approval inferred from trials. ClinicalTrials.gov — clinical-trial registry
  • surgical removal of tumors; targeted radiation in selected cases; bevacizumab (Avastin and biosimilars in drug-class context)임상시험임상시험InvestigationalEuropean Union · NF2-related schwannomatosis; source uses NF2-related terminology and vestibular schwannoma context; Vestibular schwannoma and schwannoma management, especially rapidly growing schwannomas and selected radiation/surgery contexts; not a regulator-approved NF2 drug label. · This is not a country-specific regulator approval for bevacizumab in NF2. Surgery/radiation decisions are anatomy-, age-, hearing-, growth-, and specialist-center-dependent. The CNS source explicitly notes mixed data and no coherent recommendation for bevacizumab in that update. Confidence/conflicts: Medium-high for management-option framing; source conflict/uncertainty noted because CNS did not make a bevacizumab recommendation despite describing established use in NF2-associated schwannomas. Congress of Neurological Surgeons (CNS) — clinical guideline
  • selumetinib (Koselugo)임상시험 · NCT06360406임상시험Trial only (NCT06360406)Japan · NF1 clinical/genetic condition; Pediatric NF1 PN approval-context in Japan and China; South Korea post-approval real-world study context; adult symptomatic inoperable PN trial context in multiple countries. · Japan and China approval claims are manufacturer-reported and should be followed by direct PMDA/NMPA label verification. Trial participation does not establish routine approval or reimbursement. Thailand remains source-pending for this cell. Confidence/conflicts: Medium-high for Japan/China manufacturer-reported approvals and registry geography; low for Thailand and routine Russia access because direct regulator sources were not verified. AstraZeneca — manufacturer regulatory announcement
  • bevacizumab; brigatinib; neratinib; retifanlimab; axitinib임상시험 · NCT01207687임상시험Trial only (NCT01207687)NF2-related schwannomatosis / NF2 clinical context; Progressive/symptomatic vestibular schwannoma in NF2-related contexts as defined by trial protocols. · These records do not establish FDA approval for NF2-related schwannomatosis. Trial status may be recruiting, completed, or closed, and eligibility is protocol-specific. Confidence/conflicts: High for U.S. registry status; no approval inferred from trials. ClinicalTrials.gov — clinical-trial registry

임상시험이나 초기 보고에 실렸다는 것은 해당 선택지가 연구되고 있다는 의미일 뿐, 효과가 있거나 특정 환자에게 안전하거나 현재 등록 가능하다는 뜻은 아닙니다. 어떤 선택지가 적합한지는 담당 종양내과 팀과 임상시험 팀이 함께 상의할 문제입니다. 최종 확인 2026.06.

현재 제공

국가별 선택지를 정리합니다

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

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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

  • Is the tumor a plexiform neurofibroma that is symptomatic and inoperable or not amenable to complete resection?
  • Which approved MEK inhibitor, formulation, age range, monitoring plan, and access pathway apply locally?
  • Are surgery, observation, pain/rehabilitation support, or malignant-transformation workup also part of the discussion?
  • Is the access question EMA authorization, England NICE coverage, or Germany/France reimbursement?

임상시험 검색어

Neurofibromatosis (NF1 / NF2) clinical trial