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Merck announces FDA approved KEYTRUDA.

Merck announced that the FDA has approved KEYTRUDA, Merck's anti-PD-1 therapy, for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection based on results from the EORTC1325/KEYNOTE-054 trial. This pivotal Phase 3 trial, which was conducted in collaboration with the European Organisation for Research and Treatment of Cancer, or EORTC, demonstrated that KEYTRUDA significantly prolonged recurrence-free survival, or RFS, reducing the risk of disease recurrence or death by 43% compared to placebo in patients with resected, high-risk stage III melanoma. KEYTRUDA is the first anti-PD-1 therapy studied in the adjuvant setting across patients with stage IIIA, IIIB and IIIC melanoma.

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Publication:The Fly
Date:Feb 19, 2019
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