Bristol-Myers' Opdivo-Yervoy combo scores again at FDA, this time in colorectal cancer

Bristol-Myers Squibb's Opdivo picked up an approval in colorectal cancer last August. (Bristol-Myers Squibb)

Last August, Bristol-Myers Squibb’s Opdivo nabbed an indication in certain types of colorectal cancer. And Tuesday, it took a step toward nabbing that indication again—but this time alongside fellow BMS immunotherapy Yervoy.

U.S. regulators granted the Opdivo-Yervoy pairing priority review status in previously treated patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer. And now, Bristol is expecting an FDA decision by July 10.

If the FDA greenlights the duo, patients with the MSI-H or dMMR biomarkers—who make up between 4% and 5% of metastatic colorectal cancer patients and are less likely to benefit from conventional chemo—could potentially have a better treatment option from the New Jersey drugmaker.


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January study data showed that the tandem therapy provoked responses from 55% of patients, while solo Opdivo spurred a response in 31% of patients—though Bristol’s study, CheckMate-142, didn’t formally compare the two arms.

RELATED: Bristol-Myers Squibb's Opdivo nabs MSI-H colorectal cancer nod, but it can't match Keytruda's umbrella approval

A new Opdivo-Yervoy approval could also help Bristol extend its reach in a field where it's battling longtime foe Keytruda from Merck. Opdivo’s nemesis got a go-ahead in the patient population last May, but the one it received is broader; it covers solid tumors in any part of the body as long as they bear the MSI-H genetic features.

RELATED: Bristol-Myers' Opdivo-Yervoy team scores coveted win in first-line lung cancer

Meanwhile, BMS continues to rack up regulatory milestones for the Opdivo-Yervoy marriage, which already boasts FDA clearance in melanoma. All eyes are on the lung cancer field, though, where the one-two punch is vying for a piece of the lucrative first-line market.

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