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FDA Accepts sBLA for Pembrolizumab as Adjuvant Therapy in Advanced Melanoma

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The U.S. Food and Drug Administration (FDA) has accepted for standard review a new supplemental biologics license application (sBLA) for pembrolizumab (Keytruda) as adjuvant therapy in the treatment of patients with resected, high-risk stage III melanoma. The Prescription Drug User Fee Act, or target action, date is February 16, 2019.

This sBLA is based on a significant benefit in recurrence-free survival demonstrated by pembrolizumab in the phase III 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 by Eggermont et al in The New England Journal of Medicine.

“EORTC1325/KEYNOTE-054 was the first trial with pembrolizumab to demonstrate a recurrence-free survival benefit in the adjuvant setting, and we continue to actively investigate pembrolizumab in the adjuvant or neoadjuvant setting across our broad clinical development program,” said Scot Ebbinghaus, MD, 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 pembrolizumab to patients with advanced melanoma earlier in their treatment.”

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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