Keytruda next as another day brings another I-O approval

The US Food and Drug Administration (FDA) has approved Keytruda (pembrolizumab) 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 are not candidates for curative surgery or radiation.

Monday’s clearance of Merck & Co’s (NYSE: MRK) anti-PD-1 therapy is the latest in the dynamic immuno-oncology (I-O) field, following Friday’s FDA approval of Bristol Myers Squibb’s (NYSE: BMY) Opdualag (nivolumab and relatlimab-rmbw) for the treatment of adult and pediatric patients aged 12 years of age or older with unresectable or metastatic melanoma.

"We have seen substantial progress in delivering treatment options for patients with advanced endometrial cancer with Keytruda, as monotherapy and in combination"The approval is based on new data from Cohorts D and K of the KEYNOTE-158 trial.