Posted by Michael Wonder on 17 Dec 2020
FDA grants priority review to Merck’s supplemental biologics license application for Keytruda (pembrolizumab) plus chemotherapy as first-line treatment for locally advanced unresectable or metastatic oesophageal and gastro-esophageal junction cancer
17 December 2020 - Application based on overall survival and progression-free survival data comparing Keytruda plus chemotherapy to chemotherapy alone from pivotal Phase 3 KEYNOTE-590 trial.
Merck today announced that the U.S. FDA has accepted and granted priority review for a new supplemental biologics license application for Keytruda, Merck’s anti-PD-1 therapy, in combination with platinum and fluoropyrimidine based chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus and gastro-esophageal junction.
This sBLA is based on data from the pivotal Phase 3 KEYNOTE-590 trial, in which Keytruda plus chemotherapy demonstrated significant improvements in the primary endpoints – overall survival and progression-free survival – versus chemotherapy in these patients regardless of PD-L1 expression status and tumour histology.
The FDA has set a Prescription Drug User Fee Act, or target action, date of 13 April 2021.
