The FDA has extended the priority review period for the biologics license application (BLA) seeking the approval of the tumor infiltrating lymphocyte (TIL) therapy lifileucel (LN-144) for the treatment of patients with advanced melanoma who progressed on or after anti–PD-1/PD-L1 therapy and targeted therapy.
Regulatory
FDA Approves Melphalan Hepatic Delivery System for Adult Patients With Unresectable Hepatic-Dominant Metastatic Uveal Melanoma
On August 14, the U.S. Food and Drug Administration (FDA) approved the HEPZATO KIT, a melphalan hepatic delivery system, as a liver-directed treatment for adult patients with metastatic uveal melanoma and unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.
Adjuvant Nivolumab Approved in Europe for Completely Resected Stage IIB or IIC Melanoma
The European Commission has approved single-agent nivolumab (Opdivo) for use in the adjuvant treatment of adult and adolescent patients aged 12 years or older who have stage IIB or IIC melanoma and who have undergone complete resection.
FDA Approves HEPZATO KIT for Adults Metastatic With Uveal Melanoma
The first liver-directed therapy for the treatment of adult with metastatic uveal melanoma is now FDA approved.