20 December 2018 - Merck today announced that the U.S. FDA has extended the action date for the supplemental biologics license application for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1%) without EGFR or ALK genomic tumor aberrations. 

The application is based on results of the Phase 3 KEYNOTE-042 trial where Keytruda monotherapy demonstrated a significant improvement in overall survival compared with chemotherapy in this patient population. 

The company recently submitted additional data and analyses to the FDA, which constitutes a major amendment and extends the Prescription Drug User Fee Act (PDUFA), or target action date, by three months to April 11, 2019. Merck continues to work closely with the FDA during the review of this sBLA.

Read Merck press release