BMS' Opdivo wins lung cancer indication more than 3 months before PDUFA date
UPDATE: The FDA on Wednesday approved Bristol-Myers Squibb's Opdivo for the treatment of advanced squamous non-small cell lung cancer (NSCLC) in patients who have already been treated with platinum-based chemotherapy. Opdivo is now the first drug in the novel PD-1 inhibitor class to win a lung cancer indication.
The FDA granted Opdivo a priority review status for this indication just five days ago, with a listed PDUFA date of June 22, 2015. Its approval on Wednesday means that it won the agency's blessing more than three months ahead of its PDUFA deadline, making it one of the most rapid (if not the most rapid) priority review drug approval in the agency's history. Opdivo will now have a distinct first-to-market advantage over competing PD-1 drugs vying for a lung cancer approval, such as Merck's Keytruda.
"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," said Dr. Michael Giordano, SVP and Head of Oncology Development at Bristol-Myers Squibb, in a statement. "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."
- The FDA has granted Bristol-Myers Squibb's Opdivo (nivolumab), a PD-1 inhibitor, priority review for second-line treatment of advanced squamous non-small cell lung cancer (NSCLC). (Note: Updated above).
- The PDUFA date is June 22, 2015.
- The submission is based on data from a phase II trial—the CheckMate-063 trial.
If Opdivo is approved by the FDA, it will become the first PD-1 inhibitor approved for the treatment of advanced squamous cell NSCLC.
Opdivo is already approved for the treatment of untreatable melanoma that cannot be surgically excised. In the Checkmate trial, 41% of patients survived at least a year, compared with an average survival rate of 5.5% to 18%.
Approval after phase II is usually conditional, meaning that additional phase III trials are still necessary during the post-marketing stage. However, given the strength of the results, Opdivo could be approved by the PDUFA date. At the same time, Merck's Keytruda (pembrolizumab) is in trials for the same indication and could receive approval later this year as well—but if BMS nabs it first, it will have won an important first-to-market advantage for this indication.
- Pharma Times US priority review for B-MS' Opdivo in lung cancer
- FDA FDA expands approved use of Opdivo to treat lung cancer
- Bristol-Myers Squibb U.S. Food and Drug Administration Accepts Biologics Licensing Application for Opdivo (nivolumab) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer