Posted by Michael Wonder on 31 Jul 2019
FDA approves new monotherapy indication for Merck’s Keytruda (pembrolizumab)
31 July 2019 - Keytruda now approved for recurrent locally advanced or metastatic squamous cell carcinoma of the oesophagus in patients whose tumours express PD-L1 (CPS ≥10) with disease progression after one or more prior lines of systemic therapy.
Merck today announced that the U.S. FDA has approved Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the oesophagus whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
The approval was based on data from KEYNOTE-181, a multi-center, randomized, open-label, active-controlled trial that enrolled 628 patients with recurrent locally advanced or metastatic oesophageal cancer who progressed on or after one prior line of systemic treatment for advanced disease.
