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BMS’ cancer drug Opdivo gets FDA approval to treat NSCLC

The US Food and Drug Administration (FDA) has granted approval for Bristol-Myers Squibb's (BMS) Opdivo (nivolumab) injection, for intravenous use, to treat patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

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The company said that Opdivo is the first and only programed death receptor-1 (PD-1) therapy to show overall survival in previously treated metastatic squamous NSCLC.

The approval is the second for Opdivo in the US within three months, and is based on the results of CheckMate -017 and CheckMate -063 trials.

In a prespecified interim analysis of a Phase III clinical trial, Opdivo showed superior overall survival (OS) vs. docetaxel, with a 41% reduction in the risk of death.

The median OS was 9.2 months in the Opdivo arm and 6 months in the docetaxel arm.

Bristol-Myers Squibb chief executive officer Lamberto Andreotti said: "Bristol-Myers Squibb is committed to patients with lung cancer, and we are pleased to offer Opdivo as the first immuno-oncology therapy for patients who have previously treated metastatic squamous NSCLC.

"Because lung cancer is one of the most commonly diagnosed cancers in the US, with high mortality, there is a significant need for treatments that extend survival."

The open-label, randomized, multinational, multicenter Phase III CheckMate -017 trial evaluated Opdivo vs. standard of care, docetaxel, in patients with metastatic squamous NSCLC who had progressed during or after prior platinum doublet-based chemotherapy regimen.

In January 2015, the trial was stopped based on an evaluation conducted by the independent Data Monitoring Committee (DMC), which concluded that the trial met its endpoint, showing superior OS in patients receiving Opdivo compared to docetaxel.


Image: Bristol-Myers’ Opdivo injection is approved by FDA to treat patients with metastatic squamous NSCLC. Photo: courtesy of Baitong333/freedigitalphotos.net