Iovance Biotherapeutics BLA for Melanoma Therapy

Iovance Biotherapeutics has completed a rolling BLA submission for lifileucel, a tumor infiltrating lymphocyte (TIL) therapy for treating patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy and targeted therapy. The company says it is seeking an accelerated approval for the therapy.

The submission is based on clinical data from the C-144-01 clinical trial in patients with advanced post-anti-PD1 melanoma. “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,” the company says. “TILVANCE-301 is intended to support full approval of lifileucel in post-anti-PD-1 advanced melanoma and is also designed to support registration for lifileucel in combination with pembrolizumab as therapy for advanced melanoma in the frontline setting.”