Priority review for Opdivo and chemo in cHL
US pharma major Bristol Myers Squibb (NYSE: BMY) has announced progress for its multi-indication cancer drug Opdivo (nivolumab) in another oncology setting.
The US Food and Drug Administration (FDA) has accepted and granted priority review to the supplemental Biologics License Application (sBLA) for the PD-1 immune checkpoint inhibitor alongside doxorubicin, vinblastine and dacarbazine (AVD) for adult and pediatric patients aged 12 years and older with previously untreated stage III or IV classical Hodgkin Lymphoma (cHL).
A Prescription Drug User Fee Act (PDUFA) goal date of April 8, 2026 has been set by the agency.
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