FDA approves new Opdivo indications for upper gastroesophageal cancers

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.

First FDA approved in 2014 for advanced melanoma, Opdivo has won a score of oncology indications over the years.

The drug now has five indications covering upper gastroesophageal cancers.

The two recent approvals are based on data from the Phase 3 CheckMate -648 trial, which Bristol Myers Squibb notes is the largest Phase 3 trial of an immunotherapy in first-line ESCC. In that study, Opdivo with chemotherapy offered a superior overall survival rate than chemotherapy alone.

Opdivo with Yervoy also led to improved survivability…

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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. The drug would be the third distinct checkpoint inhibitor from Princeton, New Jersey–based Bristol Myers Squibb to help appropriate patients. 

Nivolumab, whose brand name is Opdivo, generated $6.9 billion in sales last year. The drug came in at slot 10 in our list of best-selling pharmaceuticals in 2020. Nivolumab targets programmed cell death protein 1 (PD-1).   

“Although we’ve seen significant advances in the treatment of melanoma since the introduction of immune checkpoint inhibitors, there remain patients who could benefit from a novel dual immunotherapy approach,” said Jonathan Che…

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Immunotherapy against cancer: Challenge and opportunities

Image from Wikipedia.

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 new era.  

More than ever, we need clinical trials that can incorporate the required innovations into their design, conduct, infrastructure and analysis. Fortunately, specialist CROs stand ready to take what they have learned from the past 10 years of oncology drug development and apply it to the new world in which we find ourselves. 

These CROs already know how to meet the challenges of segmented study populations and an increasingly competitive development landscape, how to implement complex and adaptive…

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