21 March 2022 - Today, the FDA approved pembrolizumab (Keytruda, Merck), as a single agent, for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), as determined by an FDA approved test, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
Today, the FDA also approved the VENTANA MMR RxDx Panel (Ventana Medical Systems / Roche Tissue Diagnostics) as a companion diagnostic device to select patients with dMMR in solid tumours that are eligible for treatment with pembrolizumab.