European Regulators Postpone Bristol-Myers Squibb’s Opdivo Decision Until April or Later, As Markets Wait Anxiously
March 27, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
European regulators have decided to wait to recommend approval Bristol-Myers Squibb Company ’s possible blockbuster cancer drug Opdivo, saying that although its consideration was on its agenda, it will postpone the decision until April or even later.
A spokeswoman for the European Medicines Agency said on Friday that the nivolumab application will come up for consideration during a later meeting, as the committee takes more time to gather more information about the drug.
Some patients in Britain will continue to receive the experimental drug, which has been closely watched because of its massive success in recent trials.
Shares of Bristol-Myers Squibb Co. (BMY) skyrocketed in mid-January after the company said it had halted a late-stage study of the immunotherapy lung cancer drug after it had shown so much success further study was superfluous. The U.S. Food and Drug Administration (FDA) gave breakthrough status to Opdivo breakthrough in May, and green-lit the drug to treat skin cancer in December.
Opdivo (nivolumab) is PD-1 inhibitor that uses the body’s own immune system to help target and destroy tumors. Bristol-Myers said it stopped the trial early because the study had met its primary endpoint and had shown a survival advantage that was significant enough to review the data and perhaps push into regulatory approval faster than expected.
Bristol-Myers had parsed the data from a randomized lung cancer study pitting Opdivo against chemotherapy drug docetaxel, and found a better survival rate for the 272 patients who got doses of Opdivo every two weeks, compared to docetaxel every three.
“CheckMate -017 investigators are being informed of the decision to stop the comparative portion of the trial. Bristol-Myers Squibb is working to ensure that eligible patients will be informed of the opportunity to continue or start treatment with Opdivo in an open-label extension as part of the company’s commitment to providing patient access to Opdivo, and characterizing long-term survival,” said the company in a statement.
“The company will complete a full evaluation of the final CheckMate-017 data and work with investigators on the future presentation and publication of the results.”
In related news, competitor Merck & Co. said at the beginning of January that its own PD-1 drug, Kytruda, which was the first anti-PD drug approved by the U.S. Food and Drug Administration in September, could soon be approved for more uses. Merck said Monday it is on track to ask the FDA for a biologics license for Keytruda to treat additional types of small lung cancer. Both Opdivo and Keytruda are approved to treat patients who have not responded to other treatments previously.
Merck made the announcement ahead of the opening of the J.P. Morgan Healthcare Conference in San Francisco and the oldest and is largest conference of its type. It included 300 of the largest biotech, healthcare and biopharma companies presenting their top-line data and estimates to a sea of eager bankers, analysts, institutional investors, hedge funds and journalists.
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