Bristol Myers Squibb: received EU approval

(CercleFinance.com) - Bristol Myers Squibb receives European Commission approval for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first-line treatment of adult patients with metastatic colorectal cancer with high microsatellite instability or deficient mismatch repair.


This approval is based on the results of the phase 3 CheckMate -8HW trial, in which the dual immunotherapy combination of Opdivo plus Yervoy demonstrated a statistically significant and clinically meaningful reduction in the risk of disease progression or death compared with the choice of chemotherapy.

With this approval, Opdivo plus Yervoy is the first dual checkpoint inhibitor therapy approved in the European Union for the first-line treatment of MSI-H/dMMR mCRC.

' Colorectal cancer is the second leading cause of cancer death in Europe, and patients need new treatment options to delay disease progression. Approximately 5-7% of patients with metastatic colorectal cancer have MSI-H/dMMR tumors, and these patients are less likely to benefit from conventional chemotherapy and generally have a poor prognosis,' said Dana Walker, M.D., M.S.C.E., Vice President, Global Opdivo Program Lead, Bristol Myers Squibb.

' The EC's decision to approve Opdivo plus Yervoy represents an important milestone for this patient population in the European Union and underscores our commitment to advancing treatment options. '

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