EC Approves Bristol Myers' Opdivo - Yervoy For Mismatch Repair Deficient Treatment

(RTTNews) - Bristol Myers Squibb (BMY) said that the European Commission has approved Opdivo or nivolumab plus Yervoy or ipilimumab for the treatment of adult patients with mismatch repair deficient or dMMR or microsatellite instability-high or MSI-H metastatic colorectal cancer or mCRC after prior fluoropyrimidine-based combination chemotherapy.

The approval was based on results from the Phase 2 CheckMate - 142 trial in which Opdivo plus Yervoy demonstrated a clinically meaningful improvement in objective response rate (ORR) in patients with MSI-H/dMMR mCRC who received prior treatment with fluoropyridine, oxaliplatin and irinotecan.

The safety profile for Opdivo plus Yervoy was consistent with previous studies of the combination in other tumor types.

The combination of Opdivo plus Yervoy is the first approved dual immunotherapy treatment option for any GI tumor in the European Union (EU). The combination is also approved in the EU for non-small cell lung cancer and renal cell carcinoma.

The Marketing Authorization approves use of Opdivo plus Yervoy in all EU member states, as well as Norway, Iceland and Liechtenstein.

Opdivo plus Yervoy-based combination is now indicated in the European Union for five different advanced cancer types: mesothelioma, non-small cell lung cancer, melanoma, renal cell carcinoma and colorectal cancer.

Opdivo plus Yervoy received approval from the U.S. Food and Drug Administration (FDA) in July 2018 for the treatment of adult and pediatric patients 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.

Opdivo plus Yervoy was also approved in Japan by the Ministry of Health, Labour and Welfare (MHLW) in September 2020 for the treatment of MSI-H unresectable advanced or recurrent colorectal cancer progressing after cancer chemotherapy.