FDA approves companion diagnostic for KEYTRUDA

Feb. 23, 2022

Foundation Medicine announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic to identify patients with Microsatellite Instability High (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s KEYTRUDA (pembrolizumab).

“In tumors that are defined as MSI-H, the DNA repair mechanisms are faulty, and as a result, tumor cells can acquire a significant number of mutations that can make them recognizable by the immune system. MSI-H status is more commonly found in colorectal, endometrial and gastrointestinal cancers, but it can also be seen in other types of cancer,” Foundation Medicine said.

 KEYTRUDA was granted accelerated approval to treat certain patients with MSI-H solid tumors in May 2017, making it the first targeted therapy approved to treat patients based on a genomic signature, instead of where the tumor originated in the body, Foundation Medicine said.

“Immunotherapy has huge promise as a potential treatment option for patients with advanced cancer; however, identifying those who may benefit is complex and requires high-quality diagnostics,” said Mia Levy, MD, PhD, Chief Medical Officer at Foundation Medicine. “Not only could this approval allow more patients to benefit from KEYTRUDA, but it also underscores an important shift toward tumor-agnostic cancer care.”

Foundation Medicine has a suite of genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials.

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