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FDA Reviewing Iovance's BLA for Melanoma TIL Therapy; Decision Expected in November

NEW YORK – Iovance Biotherapeutics said on Friday that the US Food and Drug Administration has accepted its biologics license application seeking approval for lifileucel as a treatment for advanced melanoma.

The agency is slated to decide whether to approve the unselected autologous tumor infiltrating lymphocyte (TIL) therapy by Nov. 25.

After delaying its projected FDA filing for the TIL therapy for several years, in August 2022, Iovance began submitting data through a rolling BLA. The company submitted data from the Phase II C-144-01 clinical trial, in which advanced melanoma patients who have been previously treated with immune checkpoint inhibitors and targeted therapies received lifileucel.

If the FDA grants accelerated approval to the one-time TIL therapy, Iovance will have to do a study confirming the treatment's benefit in order to garner full approval. Iovance said the randomized Phase III TILVANCE-301 trial in frontline melanoma, which it expects to be underway by late November, could fulfill this requirement toward full approval.

According to the company, the FDA isn't planning to hold an advisory committee meeting to discuss the data it has submitted on lifileucel and has not flagged any review issues this time around.

When Iovance tried to submit the application in the past, the FDA pushed back on details surrounding the potency assay that Iovance planned to use to ensure the treatment had its intended activity. Ultimately, the firm announced that it would use a potency matrix approach, whereby it incorporates multiple measures of lifileucel's potency into a multifaceted series of assays as opposed to a single assay.

If lifileucel is approved for metastatic melanoma, it will be the first one-time autologous cell therapy approved for a solid tumor indication. The FDA has also deemed lifileucel a regenerative medicine advanced therapy in this treatment setting.