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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 (a suppl

Eisai to Present Investigational Data from Oncology Pipeline at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women s Cancer

Eisai to Present Investigational Data from Oncology Pipeline at the Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women s Cancer Pivotal Data on KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Versus Chemotherapy in Patients with Advanced Endometrial Cancer to be Presented During Plenary Session Additional Plenary Session to Include Investigational Data on Farletuzumab Combination with Carboplatin in Patients with Low CA125 Platinum-Sensitive Ovarian Cancer News provided by Share this article Share this article WOODCLIFF LAKE, N.J., March 10, 2021 /PRNewswire/  Eisai will present two abstracts at the virtual Society of Gynecologic Oncology (SGO) 2021 Annual Meeting on Women s Cancer, March 19-25 (#SGOMtg). These investigational data include the first presentation of efficacy and safety results from the KEYNOTE-775/Study 309 study, a multi-center, randomized, open-label, Phase 3 trial (NCT03517449) evaluating KEYTRUDA in combination with LENVIMA in certa

KEYTRUDA® Plus LENVIMA® Demonstrated Superior Progression-Free Survival and Overall Survival Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

KEYTRUDA Plus LENVIMA Significantly Reduced Risk of Disease Progression or Death by 61% Versus Sunitinib, With a Median PFS of Nearly Two Years Versus Nine Months for Sunitinib LENVIMA Plus Everolimus Significantly Improved PFS and Objective Response Rate Versus Sunitinib First Results From Pivotal CLEAR Study Presented at 2021 Genitourinary Cancers Symposium and Published in the New England Journal of Medicine … KEYTRUDA Plus LENVIMA Significantly Reduced Risk of Disease Progression or Death by 61% Versus Sunitinib, With a Median PFS of Nearly Two Years Versus Nine Months for Sunitinib LENVIMA Plus Everolimus Significantly Improved PFS and Objective Response Rate Versus Sunitinib First Results From Pivotal CLEAR Study (KEYNOTE-581/Study 307) Presented at 2021 Genitourinary Cancers Symposium (ASCO GU) and Published in the New England Journal of Medicine

Eisai to Present Investigational Data on LENVIMA® (lenvatinib) Based Combination Therapies in Renal Cell Carcinoma at the 2021 Genitourinary Cancers Symposium

Eisai to Present Investigational Data on LENVIMA® (lenvatinib) Based Combination Therapies in Renal Cell Carcinoma at the 2021 Genitourinary Cancers Symposium Data include the first presentation of results from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307) evaluating KEYTRUDA® (pembrolizumab) plus LENVIMA and LENVIMA plus everolimus News provided by Share this article Share this article WOODCLIFF LAKE, N.J., Jan. 27, 2021 /PRNewswire/  Eisai will present four abstracts at the virtual Genitourinary Cancers Symposium 2021 (#GU21) from February 11-13, 2021. These investigational data include a late-breaking oral presentation from the pivotal Phase 3 CLEAR study (KEYNOTE-581/Study 307) (NCT02811861) (Abstract # 269) evaluating KEYTRUDA plus LENVIMA and LENVIMA plus everolimus versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Dr Richard Woodman Appointed Chief Clinical Officer of the Oncology Business Group at Eisai Inc

Share this article WOODCLIFF LAKE, N.J., Jan. 20, 2021 /PRNewswire/  Eisai Inc., the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., today announces the immediate appointment of Dr. Richard Woodman as Chief Clinical Officer (CCLO) of its Oncology Business Group. In this role, Dr. Woodman will have full oversight and responsibility for the strategic and operational leadership of the company s global oncology clinical development functions, including clinical research, clinical operations, imaging, medical writing, data services, biostatistics and regulatory strategy. He will also serve as a member of the Oncology Executive Leadership team. Dr. Richard Woodman Dr. Woodman, who has 18 years of pharmaceutical experience in several different functional areas at both large and small biotech organizations, will lead the clinical team s development of Eisai s next generation oncology products by managing the design protocols and implementation of all oncology clinical trials. He w

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