A new FDA approval may help doctors identify which people with endometrial cancer (EC) could benefit from treatment with the combination of KEYTRUDA (pembrolizumab) and LENVIMA (lenvatinib).
The agency has approved the Promega OncoMate MSI Dx Analysis System as a companion diagnostic for microsatellite stable (MSS) advanced endometrial carcinoma, according to an announcement by Promega.
The approval, announced on Nov. 11, allows clinicians to use the test to determine whether a person’s tumor is MSS—meaning it does not show high levels of microsatellite instability (MSI-H). MSI status can help guide treatment decisions, including whether the KEYTRUDA plus LENVIMA combination may be an appropriate option.
Read more about endometrial cancer testing and diagnosis
OncoMate MSI Dx is a polymerase chain reaction (PCR)–based test designed to analyze tumor tissue for MSI status. MSI describes changes that occur when a tumor’s DNA repair system is not working properly. Determining whether a tumor is MSI-H or MSS can support personalized treatment planning across several cancer types, including endometrial carcinoma.
“This approval underscores the critical role diagnostics play in accurately matching the right patients, at the right time with the right therapy,” said Alok Sharma, Global Clinical Market Director at Promega.
The decision marks the first FDA-approved companion diagnostic from Promega. The company collaborated with Merck, which co-markets KEYTRUDA plus LENVIMA with Eisai, to support the regulatory process and expand access to diagnostic tools that guide informed treatment choices.
Before this decision, OncoMate MSI Dx had already received FDA clearance as the first PCR-based molecular diagnostic used to identify people with colorectal cancer who may need further testing for Lynch syndrome, a hereditary cancer condition. Outside the United States, Promega’s MSI technologies have also earned regulatory authorizations in China and the European Union.
The new approval applies to the United States and its territories. As companion diagnostics become more integrated into cancer care, tools that help determine MSI status may allow clinicians to tailor therapy more precisely for people living with advanced endometrial carcinoma.
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