Merck Receives EMA’s CHMP Positive Opinion for Keytruda (pembrolizumab) to Treat MSI-H or dMMR Tumors in Different Types of Cancer
- The EMA’s CHMP has adopted a positive opinion recommending the approval of Keytruda for MSI-H or dMMR tumors in adults with unresectable or metastatic colorectal cancer, EC, gastric, small intestine, or biliary cancer who have disease progression on or following one prior therapy
- The recommendation was based on the P-II (KEYNOTE-158) trial & P-II (KEYNOTE-164 trial) that supported the US FDA’s accelerated approval of Keytruda for MSI-H or dMMR solid tumors, regardless of tumor type
- Additionally, the EC will review the CHMP’s recommendation for the marketing authorization of Keytruda in the EU with an expected final EC’s decision in Q2’22
Ref: Merck | Image: Merck
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