Bristol Myers Squibb application for Opdivo Plus Yervoy for MSI-H/ dMMR colorectal cancer accepted by USFDA
Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Opdivo (nivolumab) plus Yervoy (ipilimumab) as a potential first-line treatment option for adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC).
The FDA granted the application Breakthrough Therapy Designation and Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025.
“The milestone brings us one step closer to providing an effective dual immunotherapy treatment option to adult and pediatric patients with microsatellite instability–high or mismatch repair deficient metastatic colorectal cancer,” said Dana Walker, M.D., M.S.C.E., vice president, Opdivo global program lead, Bristol Myers Squibb. “We look forward to potentially bringing a new standard of care treatment option to this patient population.”
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