FDA approves first-line immunotherapy for patients with MSI-H/dMMR metastatic colorectal cancer


26 June 2020 - Today, the U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. 

This marks the first immunotherapy approved for this patient population as a first-line treatment and which is administered to patients without also giving chemotherapy.

The FDA’s approval for this indication was based on the results of one multicenter, international, open-label, active-controlled, randomised trial that compared Keytruda with chemotherapy treatment in 307 patients with MSI-H or dMMR metastatic colorectal cancer.

Read FDA press release

Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US