The FDA’s CTGTAC voted that the data from the IGNYTE trial are evaluable and clinically meaningful for RP1/nivolumab in advanced cutaneous melanoma.

The Cellular, Tissue, and Gene Therapies Advisory Committee will review Replimune’s twice-rejected BLA for RP1 plus nivolumab in advanced melanoma.

The FDA issued final guidances on performance status, washout periods, and laboratory values aimed at expanding oncology trial participation.

PRAME-directed therapies represent a novel approach in the treatment of advanced melanoma.

A research team from Huntsman Cancer Institute at the University of Utah showed a pathway-targeted therapy that could be an effective melanoma treatment.