FDA grants full approval to Keytruda in tumor-agnostic setting; Candel pauses trial enrollment

In a first, Merck has secured a full approval for Keytruda in a tumor agnostic setting — as a treatment for any unresectable or metastatic solid tumors that are classified as microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).

The FDA granted Keytruda accelerated approval in this indication in 2017, and GSK’s Jemperli followed suit in 2021. But now it’s converted to a full approval for Keytruda. Before prescribing, doctors would have to make sure patients carry this biomarker, using an FDA-approved test.

Merck pooled data — mainly overall response rates — from three open-label trials to support this filing. The first enrolled 124 patients with advanced MSI-H/dMMR colorectal cancer that progressed after chemo; the second enrolled 373 patients with advanced MSI-H/dMMR non-colorectal cancers who progressed following prior therapy; and the third comprised seven pediatric patients with MSI-H/dMMR cancers.

By Merck’s analysis, Keytruda showed an ORR of 33.3% across these…
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