Bristol Myers Squibb (NYSE:BMY) has won FDA approval for Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based chemotherapy as a first-line treatment for adults with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). The agency also approved Opdivo with Yervoy (ipilimumab) for ESCC. Both approvals cover ESCC regardless of programmed death-ligand 1 (PD-L1) status.…
FDA accepts priority review for BMS’s relatlimab and nivolumab in melanoma
Bristol Myers Squibb (NYSE: BMY) has won priority review for its Biologics License Application for the fixed-dose combination of the checkpoint inhibitors relatlimab and nivolumab to treat patients 12 and older who weigh at least 40 kg (88 pounds) with unresectable or metastatic melanoma. Relatlimab would be a novel lymphocyte-activation gene 3 (LAG-3) blocking antibody.…
Immunotherapy against cancer: Challenge and opportunities
With some of the recently developed drugs showing unprecedented response rates and consistent improvement in overall survival in some indications, we face the dawn of a new era in anticancer research. New therapeutic targets, novel classes of products, booming and competing pipelines, innovative statistical methods, and a changing regulatory environment are all features of this…