FDA approves FoundationOne CDx to identify patients with MSI-high tumors for pembrolizumab
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The FDA approved FoundationOne CDx as a companion diagnostic to identify patients with microsatellite instability-high solid tumors who may benefit from pembrolizumab, according to a press release from the test’s manufacturer.
FoundationOne CDx (Foundation Medicine) uses DNA isolated from formalin-fixed, paraffin-embedded specimens of tumor tissue to detect substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, in addition to genomic signatures such as tumor mutational burden and microsatellite instability (MSI), found most often in endometrial and gastrointestinal cancers, including colorectal cancer.
Pembrolizumab (Keytruda, Merck), an anti-PD-1 antibody, received FDA accelerated approval in 2017 for treatment of certain patients with MSI-high solid tumors.
“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,” Mia Levy, MD, PhD, chief medical officer of Foundation Medicine, said in a press release. “Not only could this approval allow more patients to benefit from Keytruda, but it also underscores an important shift toward tumor-agnostic cancer care.”
The FoundationOne CDx test also has been approved to identify patients with tumor mutational burden-high solid tumors who may benefit from pembrolizumab. The test now has 26 companion diagnostic claims and two group claims across 27 targeted therapies, according to the press release.
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