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Enfortumab Vedotin in Urothelial Carcinoma urotoday.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from urotoday.com Daily Mail and Mail on Sunday newspapers.
Japan s Ministry of Health, Labour and Welfare Grants Priority Review for Enfortumab Vedotin New Drug Application NDA, submitted in March, is for locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication News provided by Share this article Share this article TOKYO, May 13, 2021 /PRNewswire/ Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Astellas ) today announced Japan s Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company s New Drug Application (NDA), which was submitted in March. If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in Japan for the treatment of patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication. ....
(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 progressi ....
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 ....
Testicular, Penile, and Rare GU Malignancies Interviews with Experts at Conferences Curated by clinicians: educational forums with videos, abstracts and conference information Videos April 27, 2021 The State-of-the-Evidence in Brief Reviews by Experts May 17, 2021 Penile cancer (PC) is a rare malignancy with an incidence estimated less than 1/100 000 per year in the Western World 1-3 Historically, demolitive surgical approaches, such as total or partial penile amputation, were the most commonly used. Indeed, demolitive options were deemed to be necessary in order to respect a macroscopic surgical margin of at least 2 cm. 3-4 If the oncological outcomes of these approaches demonstrated to be satisfactory, they significantly affected aesthetic outcomes, as well as sexual and urinary functions. ....