Merck announces FDA acceptance of supplemental Biologics License Application for KEYTRUDA

Merck, known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma and granted a Prescription Drug User Fee Act (PDUFA), or target action, date of February 16, 2019. This sBLA is based on a significant benefit in recurrence-free survival demonstrated by KEYTRUDA in the pivotal Phase 3 EORTC1325/ KEYNOTE-054 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer (EORTC). These data were presented for the first time at the American Association for Cancer Research (AACR) Annual Meeting 2018 and published in The New England Journal of Medicine.

"EORTC1325/KEYNOTE-054 was the first trial with KEYTRUDA to demonstrate a recurrence-free survival benefit in the adjuvant setting, and we continue to actively investigate KEYTRUDA in the adjuvant or neoadjuvant setting across our broad clinical development program," said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. "Earlier intervention with adjuvant therapy has proven to be an important factor in reducing the risk of recurrence following surgery for patients with high-risk stage III melanoma. We look forward to working with the FDA on the review of this application, with the goal of bringing KEYTRUDA to patients with advanced melanoma earlier in their treatment."

Merck's long-term commitment to melanoma includes a broad clinical development program studying KEYTRUDA as monotherapy and in combination with other novel mechanisms. The program, which is comprised of more than 4,500 patients across 10 Merck-sponsored clinical studies, is evaluating KEYTRUDA across most settings and stages of the disease.