The US Food and Drug Administration (FDA) has agreed to review a supplemental biologics license application (sBLA) submitted by Bristol-Myers Squibb for the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) to treat metastatic colorectal cancer (mCRC).

Opdivo is an immune checkpoint inhibitor of programmed death-1 (PD-1) and uses the body’s own immune system to restore anti-tumour immune response, while Yervoy is a monoclonal that triggers the immune system by targeting CTLA-4 protein.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

The application seeks approval for adults with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) mCRC that has progressed after being treated with fluoropyrimidine, oxaliplatin and irinotecan.

dMMR is caused by missing or non-functioning proteins that repair mismatch errors in DNA replication, which results in MSI-H tumours.

“The FDA acceptance of this application with priority review reinforces our belief in the potential of the Opdivo plus Yervoy combination to treat patients with previously treated mCRC.”

Bristol-Myers Squibb gastrointestinal cancers development lead Ian Waxman said: “The FDA acceptance of this application with priority review reinforces our belief in the potential of the Opdivo plus Yervoy combination to treat patients with previously treated mCRC defined by MSI-H or dMMR biomarkers, and is a result of our longstanding commitment to the exploration of I-O/I-O combinations for patient populations with high unmet need.

“We look forward to working with the FDA with the goal of bringing this combination to these colorectal cancer patients.”

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The sBLA includes data from the Phase II clinical trial currently being conducted to assess the combination therapy in previously treated patients suffering from MSI-H or dMMR mCRC.

It is estimated that more than 140,000 new cases of colorectal cancer are diagnosed in the US each year. The disease is the third most common cancer.

The FDA awarded priority review to the sBLA and the FDA action date is 10 July.