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news.The US Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb's biologics licensing application (BLA) for Opdivo (nivolumab) to treat patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy.
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The agency also granted priority review for this BLA and has given the Prescription Drug User Fee Act (PDUFA) goal date of 22 June 2015 for a decision.
The FDA acceptance is based on data from CheckMate -063, a Phase II single arm, open-label trial designed to evaluate advanced squamous NSCLC patients who progressed after both platinum-based therapy and at least one additional systemic therapy.
Bristol-Myers Squibb senior vice president and head of Oncology Development Michael Giordano said: "With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population.
"As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community."
Opdivo is being evaluated by the company as monotherapy or in combination with other therapies in multiple tumor types including more than 50 trials in which more than 7,000 patients have been enrolled across the world.