FDA blessing cements landmark approval for Keytruda in USA

New Jersey, USA-based cancer giant Merck & Co (NYSE: MRK) has converted a conditional nod for its checkpoint blocker, Keytruda (pembrolizumab), into regular approval.

In 2017, Merck’s anti-PD-1 therapy won a groundbreaking regulatory first, with approval for the treatment of any solid tumor which met certain criteria, as defined by a biomarker test.

Pending confirmatory data, the US regulator granted approval for marketing of Keytruda for people with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors.