IOVANCE UP 15% ON FDA ACCEPTANCE OF LIFILEUCEL APPLICATION FOR MELANOMA
- The US FDA has accepted Iovance Biotherapeutics' (NASDAQ:IOVA) Biologics License Application for lifileucel for advanced melanoma, sending shares up ~15% in after-hours trading Friday.
- The candidate has an FDA action date of Nov. 25 as it was granted Priority Review. In addition, the agency is not planning to hold an advisory committee meeting on the application.
- Lifileucel is polyclonal tumor infiltrating lymphocyte therapy for advanced melanoma patients who have progressed while on or after anti-PD-1/L1 therapy and targeted therapy where appropriate.
- The application is supported by study data indicating a 31% objective response rate.
- Iovance (IOVA) will also conduct a phase 3 trial of lifileucel that will serve as a confirmatory study. It is expected to be underway at the time of approval.
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