NEW YORK CITY (dpa-AFX) - Bristol Myers Squibb Co. (BMY) announced Monday
that the European Medicines Agency (EMA) has validated its Type II variation
application for Opdivo (nivolumab) plus Yervoy (ipilimumab) for the first-line
treatment of adult patients with microsatellite instability-high (MSI-H) or
mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC).

The EMA's validation of the application confirms the submission is complete and
begins the EMA's centralized review process.

The submission is based on results from the CheckMate -8HW study, in which
Opdivo plus Yervoy demonstrated a statistically significant and clinically
meaningful improvement in the dual primary endpoint of progression-free survival
(PFS).

This was compared to investigator's choice of chemotherapy as assessed by
Blinded Independent Clinical Review (BICR) for the first-line treatment of
patients with MSI-H/dMMR mCRC.

The study is ongoing to assess the other dual primary endpoint of PFS in
patients receiving Opdivo plus Yervoy compared to Opdivo alone, as well as
secondary endpoints.



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