FDA Accepts Iovance’s Biologics License Application for Melanoma Treatment
Iovance Biotherapeutics, Inc. (NASDAQ: IOVA) has announced that the FDA has accepted its Biologics License Application (BLA) for lifileucel for patients with advanced melanoma.
The FDA granted lifileucel Priority Review and assigned November 25, 2023 as the target action date for a decision under the Prescription Drug User Fee Act (PDUFA).
Highlights
Lifileucel is a tumor infiltrating lymphocyte (TIL) therapy intended for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. There are no FDA approved therapies in this treatment setting.
The FDA previously granted a Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel in advanced melanoma.
If lifileucel receives accelerated approval, the company’s randomized Phase 3 TILVANCE-301 trial in frontline advanced melanoma can serve as the confirmatory study to support full approval.T
ILVANCE-301 is expected to be well underway at the time of approval.Iovance stated its gratitude for the patients and physicians who took part in the company’s clinical trials.
Iovance stated its gratitude for the patients and physicians who took part in the company’s clinical trials.
About Iovance Biotherapeutics
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. The company is pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. Iovance’s lead late-stage TIL product candidate, lifileucel for metastatic melanoma, has the potential to become the first approved one-time cell therapy for a solid tumor cancer. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. The company is committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer.
