Research record

Lifileucel tumor-infiltrating lymphocyte therapy

A T-cell therapy option to ask about after prior systemic therapy in the FDA-labeled context. It is not a simple infusion appointment and should be discussed at experienced centers.

What this is

A T-cell therapy option to ask about after prior systemic therapy in the FDA-labeled context. It is not a simple infusion appointment and should be discussed at experienced centers.

Why it may come up

  • adult melanoma that cannot be removed by surgery or has spread
  • after PD-1 blocking antibody
  • if BRAF V600 positive, after BRAF inhibitor with or without MEK inhibitor

What not to assume

  • Do not claim broad global availability.
  • Do not simplify cell therapy into ordinary immunotherapy.

At a glance

Lifileucel tumor-infiltrating lymphocyte therapy

Approved in some placesWhere it is available depends on the country.
Type
Cell therapy
Mutation result
any, BRAF V600 context affects prior-therapy requirement
Where
US
Evidence status
Approved in listed place
Last checked
2026-05-20

What we know

  • FDA accelerated approval is based on response-rate evidence, with confirmatory obligations typical of accelerated approval.
  • This should eventually become a dedicated treatment page because families often do not know TIL exists.

What is unclear

  • Do not claim broad global availability.
  • Do not simplify cell therapy into ordinary immunotherapy.

Questions to ask

  • Is a TIL therapy center appropriate to consult?
  • Would prior treatments or current disease location affect feasibility?
  • How long would manufacturing and treatment logistics take?

Timeline

  1. approval2024: FDA accelerated approval

    FDA accelerated approval for the source-cited unresectable/metastatic melanoma context after prior therapy.

Open related treatment page