Posted by Michael Wonder on 13 Jun 2018
FDA approves Merck’s Keytruda (pembrolizumab) for previously treated patients with recurrent or metastatic cervical cancer whose tumours express PD-L1 (CPS greater than or equal to 1)
12 June 2018 - Keytruda now first anti-PD-1 therapy approved for patients with advanced cervical cancer and disease progression on or after chemotherapy.
Merck today announced that the U.S. FDA has approved Keytruda, the company’s anti-PD-1 therapy, for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumours express PD-L1 [Combined Positive Score (CPS) ≥1] as determined by an FDA-approved test. This indication is approved under the FDA’s accelerated approval regulations based on tumour 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.
The efficacy of Keytruda was investigated in 98 patients with recurrent or metastatic cervical cancer enrolled in a single cohort (Cohort E) in study KEYNOTE-158, a multi-center, non-randomised, open-label, multi-cohort trial.
