FDA Grants Priority Review to Merck’s Application for New Keytruda Indication

Ther FDA has accepted Merck’s application for review and granted priority review to a new supplemental Biologics License Application (sBLA) seeking approval for Keytruda, Merck’s anti-PD-1 therapy, as monotherapy for first-line treatment of locally advanced or metastatic nonsquamous or squamous non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 (tumor proportion score [TPS] ≥1 percent) without EGFR or ALK genomic tumor aberrations.

The application is based on data from the pivotal Phase 3 Keynote-042 trial, one of five Phase 3 clinical trials with Keytruda in NSCLC to demonstrate a significant improvement in overall survival. Data from the trial were presented earlier this year at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Jan. 11, 2019.

“Keytruda is already a foundation for the treatment of metastatic non-small cell lung cancer,” said Dr. Roy Baynes, senior vice president and head of global clinical development, CMO, Merck Research Laboratories. “We are pleased that the FDA is reviewing this sBLA and we look forward to potentially extending the monotherapy indication for Keytruda to locally advanced or metastatic patients whose tumors express PD-L1, with a tumor proportion score of one percent or more.”

In addition to Keynote-042, Merck’s leading lung cancer clinical development program includes 10 Phase 3 trials with Keytruda in combination with other treatments and as monotherapy across histologies and lines of treatment in both advanced and earlier stages of disease.

(Source: Merck)