Bristol Myers Squibb's (BMY.US) groundbreaking immunotherapy combination has been granted priority review status by the FDA, with a clearance rate exceeding 70%.

Bristol Myers Squibb (BMY.US) announced that the FDA has accepted for priority review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adult and pediatric (12 years and older) patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA granted the application Breakaway Therapy designation and priority review, with an expected review date of June 23, 2025.

An analysis released in late January showed that patients treated with Opdivo in combination with Yervoy had a 38% lower risk of disease progression or death compared to Opdivo monotherapy, with a median follow-up of 47 months. At 12, 24, and 36 months, the progression-free survival rates for Opdivo in combination with Yervoy were 76%, 71%, and 68%, respectively, compared to 63%, 56%, and 51% for Opdivo monotherapy.

Moreover, the objective response rate (ORR) for Opdivo in combination with Yervoy was 71%, significantly higher than that of Opdivo monotherapy (58%, p=0.0011). Earlier results showed that Opdivo in combination with Yervoy as a first-line therapy reduced the risk of disease progression or death by 79% compared to investigator-selected chemotherapy.