Foundation Medicine, Inc. received approval from the U.S. Food and Drug Administration (FDA) for its companion diagnostic aid that is used to help identify patients with Microsatellite Instability High (MSI-H) solid tumors.
The FoundationOne CDx solution is to be used as a companion diagnostic to identify patients with MSI-H status solid tumors who may be appropriate for treatment with Merck’s KEYTRUDA.
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. KEYTRUDA was granted accelerated approval to treat certain patients with MSI-H solid tumors in May 2017.
“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,” says 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.”
This is the third tumor agnostic companion diagnostic approval for FoundationOne CDx, which now has 26 companion diagnostic claims and two group claims across 27 targeted therapies.
“We’re proud to see this collaboration with Foundation Medicine, which drew on the deep scientific expertise of both organizations, result in another companion diagnostic approval for use in identifying patients who may be appropriate for KEYTRUDA,” says Eric Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.
For more information, click here.
