Approval is based on data from Bristol Myers Squibb’s CheckMate – 76K trial.
Publications
FDA Approves Adjuvant Nivolumab for Stage IIB/IIC Melanoma
Approval is based on data from Bristol Myers Squibb’s CheckMate – 76K trial.
FDA Extends Priority Review of BLA for Lifileucel in Advanced Melanoma
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.
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.