Shares of Iovance Biotherapeutics (NASDAQ: IOVA) 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 's Keytruda (pembrolizumab) to treat advanced melanoma. Iovance specializes in using tumor-infiltrating lymphocytes as therapies to fight cancer cells. 

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.

Continue reading

Source Fool.com