FDA clears Foundation Medicine's companion diagnostic

2019 02 13 19 24 5396 Fda Logo V2 400

The U.S. Food and Drug Administration (FDA) has cleared Foundation Medicine's FoundationOne CDx companion diagnostic for identifying patients with microsatellite instability-high (MSI-H) solid tumors who may benefit from Keytruda (pembolizumab) treatment.

Characterizing these tumors helps clinicians identify patients who could benefit from immunotherapy such as Keytruda, a humanized antibody used in cancer immunotherapy, the company said. MSI-H status is a defining feature of colorectal, endometrial, and gastrointestinal cancers.

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