Merck Granted Label Expansion by FDA for Keytruda

Keytruda, Merck’s checkpoint inhibitor, has been granted label expansion by the U.S. Food and Drug Administration (FDA) for first-line treatment for patients diagnosed with, regardless of PD-L1 expression, locally advanced or metastatic gastroesophageal or esophageal junction (GEJ) carcinomas, in combination with chemotherapy. Keytrude was originally approved as a second-line treatment for patients with locally advanced, recurrent, or metastatic PD-L1-positive squamous cell carcinoma of the esophagus. The approval is based on data from749 patients with GEJ or esophageal carcinoma that participated in the Phase III KEYNOTE-590 trial.

Read more here.