2 October 2019 - Keytruda is first anti-PD-1 therapy approved as monotherapy and in combination with chemotherapy in first-line setting for NSCLC in China.
Merck today announced that Keytruda, Merck’s anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China as monotherapy for the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer whose tumours express PD-L1 (tumour proportion score [TPS] ≥1%) as determined by a NMPA-approved test, with no EGFR or ALK genomic tumour aberrations.
This new indication was granted full approval based on the overall survival findings from the Phase 3 KEYNOTE-042 trial, including data from an extension of the global study in Chinese patients.