The European Commission (EC) has granted Merck, Sharp & Dohme (MSD; NYSE: MRK) additional indications for its leading anti-PD-1 therapy, Keytruda (pembrolizumab), approving its use as a first-line treatment in combination with chemotherapy for locally advanced unresectable or metastatic biliary tract carcinoma (BTC) and HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. This marks the latest in a series of 24 oncology authorizations for Keytruda in the region.
The approval for BTC was supported by Phase III data demonstrating a 17% reduction in the risk of death, alongside an increase in median overall survival (OS) of 1.8 months when compared to chemotherapy alone. Similarly, in a separate late-stage trial for GEJ, the therapy showed a 22% decrease in the risk of death and extended median OS by 1.6 months relative to chemotherapy alone.- Flcube.com
