What happened
Shares of Iovance Biotherapeutics (IOVA -1.45%) were up more than 17% late Tuesday afternoon after the clinical-stage biotech company announced that the Food and Drug Administration (FDA) had approved its biologics license application (BLA) for lifileucel, as a combination therapy with Merck's Keytruda (pembrolizumab) to treat advanced melanoma. Iovance specializes in using tumor-infiltrating lymphocytes as therapies to fight cancer cells.
So what
Iovance announced on late Friday that the FDA had granted lifileucel Priority Review status and set a Prescription Drug User Fee Act (PDUFA) date of Nov. 25 for the cell therapy. It did not say it planned to hold an advisory committee meeting to discuss the application, and did not raise any potential issues regarding the review.
That means the chances are stronger that lifileucel, which is intended to be used on advanced melanoma patients whose cancer has progressed after prior therapies, would be the first such therapy approved for such an indication.
Iovance CEO Frederick Vogt said he was encouraged by the FDA's decision, adding, "The FDA's commitment to a six-month Priority Review validates the unmet need and urgency for new treatment options for patients with advanced melanoma who have progressed on or after standard of care therapies."
Now what
The FDA's decision was made easier by the company's C-144-01 phase 2 clinical trial on lifileucel, which demonstrated an objective response rate of 31.4% to the therapy, with nine complete responses and 39 partial responses in 153 patients. If lifileucel receives accelerated approval from the FDA, the company's planned phase 3 TILVANCE-301 trial for the therapy would serve as the confirmatory study to obtain full approval.
Iovance doesn't have any revenue yet, but in the first quarter, it reported it had $632.7 million in cash, enough to fund operations, it said, into the second half of 2024.
