FDA approves another new indication for Keytruda

Things only get better and better for US pharma giant Merck & Co’ (NYSE: MRK) blockbuster cancer drug Keytruda (pembrolizumab), which just last week was seen to be the outstanding event at the American Society of Clinical Oncology (ASCO) meeting.

On June 12, the Food and Drug Administration approved Keytruda for patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-approved test. This is sooner than the previously announced date for an FDA decision of June 28.

This indication is approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.