EU approves BMS’s treatment for metastatic colorectal cancer
pharmafile | June 30, 2021 | News story | Research and Development |
The EU has approved Opdivo (nivolumab) plus Yervoy (ipilimumab) for the treatment of metastatic colorectal cancer.
The treatment will be for adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.
The approval is based on results from the Phase II 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 tumour types.
Ian M Waxman, Development Lead, Gastrointestinal Cancers, Bristol Myers Squibb, said: “Metastatic colorectal cancer is an aggressive disease with a poor prognosis, leaving patients with a critical need for additional treatment options beyond standard chemotherapy.
“With this approval, patients in the EU with mismatch repair deficient or microsatellite instability-high metastatic colorectal cancer will now have the first dual immunotherapy treatment available to them, and we look forward to working with stakeholders to advance this rational combination.”
Opdivo plus Yervoy is the first dual immunotherapy regimen approved in the European Union for colorectal cancer.
Colorectal cancer (CRC) is cancer that develops in the colon or the rectum, which are part of the body’s digestive or gastrointestinal system. Globally, CRC is the third most commonly diagnosed cancer in the world.
In 2020, it is estimated that there were approximately 1,931,000 new cases of the disease and that it will be the second leading cause of cancer-related deaths among men and women combined.
Lilly Subbotin
