Forbes Innovation Healthcare Newly Approved Cell Therapy For Advanced Melanoma, Amtagvi, Is A Potential Breakthrough Joshua Cohen Senior Contributor Opinions expressed by Forbes Contributors are their own. I write about healthcare policy, with an emphasis on Rx drugs. Following Click to save this article.
You'll be asked to sign into your Forbes account. Got it Mar 4, 2024, 08:20am EST Share to Facebook Share to Twitter Share to Linkedin Dendritic cell activates T cells which in turn trigger immune responses. Amtagvi is the first first .
.. [+] FDA-approved T cell therapy for a solid tumor indication.
getty Based on Phase 2 data, the Food and Drug Administration has granted an accelerated approval of a promising cellular immunotherapy, Amtagvi (lifileucel), to treat advanced forms of melanoma. The accelerated approval pathway relies on surrogate endpoints rather than clinical benefit measured in terms such as extension of life or improvement of morbidity outcomes. A confirmatory Phase 3 trial is ongoing to verify Amtagvi’s clinical effectiveness.
If this is demonstrated, Amtagvi will represent an important breakthrough. Amtagvi is the first cell therapy approved by the FDA for solid tumors. It is also the first marketed treatment that uses tumor-infiltrating lymphocytes collected directly from a tumor sample and fortified in a laboratory to better fight the cancer, as PharmaVoice explains .
The newly approved medicine is similar to CAR T -cell therapies, which have mainly be.
