Posted by Michael Wonder on 23 Jun 2020
Merck’s Keytruda (pembrolizumab) approved in China for second-line treatment of patients with locally advanced or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 (CPS ≥10)
22 June 2020 - Keytruda is now approved across five indications for three different types of cancer in China and is first anti-PD-1 therapy approved for oesophageal cancer.
Merck today announced that Keytruda, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration in China as monotherapy for the treatment of patients with locally advanced or metastatic oesophageal squamous cell carcinoma whose tumours express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by a fully validated test, following failure of one prior line of systemic therapy.
This new indication was granted full approval based on the overall survival findings from the global Phase 3 KEYNOTE-181 trial, including data from an extension of the global study in Chinese patients.
