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Eisai: FDA Approves LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

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Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation
Study Results Demonstrated Statistically Significant Improvements in Overall Survival, Progression-Free Survival and Overall Response Rate, Helping to Address a Significant Unmet Need in Advanced Endometrial Carcinoma
TOKYO and KENILWORTH, N.J., July 23, 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 approved 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. ....

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FDA Approves KEYTRUDA® Plus LENVIMA® Combination for Patients With Certain Types of Advanced Endometrial Carcinoma

FDA Approves KEYTRUDA® Plus LENVIMA® Combination for Patients With Certain Types of Advanced Endometrial Carcinoma
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Eisai Data at ASCO 2021 Highlight Breadth of Oncology Portfolio Across Various Tumor Types

Eisai Data at ASCO 2021 Highlight Breadth of Oncology Portfolio Across Various Tumor Types
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Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A. Receive Priority Review From FDA for LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) Applications

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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 progressi ....

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Merck and Eisai Receive Priority Review From FDA for KEYTRUDA® Plus LENVIMA® Applications 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 Merck known as MSD outside the United States and Canada, and Eisai Inc. today announced that the U.S. Food and Drug Administration has accepted and granted priority review for applications seeking two new approvals for the combination of KEYTRUDA, Merck’s anti-PD-1 therapy, …
Applications Based on Progression-Free Survival, Overall Survival, and Objective Response Rate Data From Respective Pivotal Phase 3 Trials
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai Inc. 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 KEYTRUDA, Merck’s anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai. The first set of applications ....

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