Dr Weber discusses the FDA approval of adjuvant nivolumab for patients with completely resected stage IIB/C melanoma, key efficacy data from the CheckMate76K trial, and potential future directions for PD-1 inhibitor–based combinations in the melanoma treatment paradigm.
Regulatory
FDA Approves Nivolumab for Completely Resected Stage IIB/C Melanoma
Approval is based on data from Bristol Myers Squibb’s CheckMate – 76K trial.
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.