Bristol Myers: file accepted in colorectal cancer

(CercleFinance.com) - Bristol Myers Squibb reports that the U.
S. FDA has accepted a supplemental Biologics License Application (sBLA) for Opdivo plus Yervoy as a potential first-line treatment option in a form of colorectal cancer.

This combination is proposed for adults and children (12 years and older) with unresectable or metastatic colorectal cancer with high microsatellite instability or deficient mismatch repair.

The application is based on analyses from the CheckMate -8HW Phase 3 clinical trial, in which Opdivo plus Yervoy demonstrated progression-free survival superior to Opdivo monotherapy and investigator-selected chemotherapy.

Bristol Myers Squibb adds that the FDA has granted its application Breakthrough Therapy Designation and Priority Review status. It has set a June 23 deadline for the Prescription Drug User Fee Act (PDUFA).

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