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March 29, 2018

FDA accepts BMS’ sBLA of Opdivo and Yervoy for colorectal cancer

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).

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.

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.”

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.

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