Nivolumab sBLA Accepted for Patients With Completely Resected Stage IIB, IIC Melanoma
The sBLA is supported by data from the phase 3 CheckMate -76K trial which included 790 patients after complete resection of stage IIB or IIC melanoma.
The sBLA is supported by data from the phase 3 CheckMate -76K trial which included 790 patients after complete resection of stage IIB or IIC melanoma.
Following an initial extensive review, the Agency identified less than 20 cases of SCC and less than 30 cases of various lymphomas in the capsule around the breast implant.
Opdualag is a fixed-dose combination of nivolumab, a programmed death receptor-1 (PD-1) blocking antibody, and relatlimab, a lymphocyte activation gene-3 (LAG-3) blocking antibody.
Approval was based on data from the phase 3 KEYNOTE-716 trial, which enrolled 976 participants.
The application is supported by data from the phase 2/3 RELATIVITY-047 trial.
Nemvaleukin alfa is an investigational, engineered fusion protein consisting of modified interleukin-2 (IL-2) and the high-affinity IL-2 alpha receptor chain.
The approval was based on data from a phase 2 trial that assessed Lymphoseek in pediatric patients with melanoma, RMS, or other solid tumors.