sean,

You posted about the first cell therapy approval for solid tumors. I was not familiar with lifileucel and looked up some info on it. I saw the following in the FDA's announcement:

Quote:

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On February 16, 2024, the Food and Drug Administration granted accelerated approval to lifileucel (Amtagvi, Iovance Biotherapeutics, Inc.), a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.

The prescribing information contains a Boxed Warning for treatment-related mortality, prolonged severe cytopenia, severe infection, cardiopulmonary, and renal impairment. The most common adverse reactions (≥20%) in order of decreasing frequency were chills, pyrexia, fatigue, tachycardia, diarrhea, febrile neutropenia, edema, rash hypotension, alopecia, infection, hypoxia, and dyspnea.

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Based on the above and the price you quoted, there is plenty of room for Leronlimab in this indication if they can get approval. Thanks for the heads-up.

https://www.fda.gov/drugs/resources-informati...c-melanoma