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(1) For Advanced Renal Cell Carcinoma and for Advanced Endometrial Carcinoma Applications Based on Progression-Free Survival, Overall Survival, and Objective Response Rate Data From Respective Pivotal Phase 3 Trials TOKYO, May 7, 2021 - (JCN Newswire) - Eisai Co., Ltd.and Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside the United States and Canada) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review for applications seeking two new approvals for the combination of LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus KEYTRUDA, the anti-PD-1 therapy from Merck & Co., Inc., Kenilworth, N.J., U.S.A. The first set of applications (a supplemental New Drug Application [sNDA] for LENVIMA and a supplemental Biologics License Application [sBLA] for KEYTRUDA) are for the first-line treatment of patients with advanced renal cell carcinoma (RCC), based on progression-free surv

United statesGregory lubinieckiOncology clinical researchDrug administrationOncology business group at eisaiEisai co ltdMerck co incResearch laboratoriesSociety of gynecologic oncologyAdvanced renal cell carcinomaAdvanced endometrialProgression free survivalOverall survivalNew drug applicationBiologics license applicationPrescription drug user fee act