Bristol-Myers said the marketing application submitted to the U.S. FDA for its Opdivo plus Yervoy cancer therapy combination will be delayed by three months, until May 2019.
EU regulators had asked for more information on the therapy, including an overall survival (OS) analysis for certain types of patients. Bristol-Myers said an OS analysis for the same patient sub-group was also submitted to the FDA.
According to the drugmaker, "The FDA determined that the submission of this new information constituted a major amendment to the sBLA and notified the Company today that the review period was extended by three months with a new Prescription Drug User Fee Act goal date of May 20, 2019.”
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