Bristol Myers Colorectal Cancer Treatment Goes Under Priority FDA Review

On Monday, the FDA accepted the supplemental biologics license application (sBLA) for Bristol Myers Squibb & Co’s (NYSE:BMY) 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. It also assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025.

Also Read: What’s Going On With Bristol Myers Squibb Stock On Monday?

The application was based on results from the three-arm Phase 3 CheckMate -8HW study, which demonstrated that Opdivo plus Yervoy met the dual primary endpoints of progression-free survival (PFS) compared to the investigator’s choice of chemotherapy in the first-line setting and compared to Opdivo monotherapy across all lines of therapy.

Opdivo plus Yervoy received FDA approval in July 2018 for adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that have progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan. 

Opdivo plus Yervoy was also approved in December 2024 in the European Union for the first-line treatment of adult patients with MSI-H or dMMR unresectable or mCRC and in October 2024 for the same indication by the China National Medical Products Administration.

Last week, Bristol Myers announced the final analysis of overall survival (OS) from the Phase 3 CheckMate -816 study. The trial evaluated Opdivo (nivolumab) in combination with platinum-doublet chemotherapy as a neoadjuvant treatment for adult patients with resectable non-small cell lung cancer (NSCLC).

The results showed a statistically significant and clinically meaningful improvement in overall survival, a key secondary endpoint, compared to neoadjuvant chemotherapy alone.

Price Action: Bristol Myers stock is up 2.97% at $57.49 at last check Monday.

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Image: Courtesy of Bristol Myers Squibb