Iovance Biotherapeutics (NASDAQ:IOVA) shares are trading higher on Monday after the company completed its Biologics License Application submission for lifileucel.
Lifileucel is a tumor infiltrating lymphocyte therapy intended as a treatment for patients with advanced melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy, where applicable. There are no FDA approved therapies in this treatment setting.
The BLA submission for lifileucel is supported by positive clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. Following a successful pre-BLA meeting with the FDA, Iovance is pursuing accelerated approval in this indication.
Iovance also reached agreement with the FDA regarding the registrational trial design for the Phase 3 TILVANCE-301 trial of lifileucel in combination with pembrolizumab in frontline advanced melanoma.
Frederick Vogt, Ph.D., J.D., Interim President and CEO of Iovance, stated, “Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, one-time cell therapy for a solid tumor. Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.”
Iovance Biotherapeutics aims to be the global leader in innovating, developing and delivering tumor infiltrating lymphocyte therapies for patients with cancer.
IOVA Price Action: Iovance has a 52-week high of $18.72 and a 52-week low of $5.39
Iovance shares are up 9.95% at $6.08 at the time of writing, according to Benzinga Pro.
