Tag: bladder cancer
Enfortumab Vedotin + Pembrolizumab Significantly Extends OS and PFS in...
Results from the Phase 3 EV-302/KEYNOTE-A39 clinical trial for enfortumab vedotin (Padcev®; Astellas/Seagen) in combination with pembrolizumab (Keytruda®; Merck & Co/MSD) versus chemotherapy, presented at the European Society for Medical Oncology (ESMO) Congress 2023
Combination of Enfortumab Vedotin with Pembrolizumab Shows Positive Topline Results as...
Cisplatin-based combination chemotherapy has been widely accepted as the first-line treatment option for cisplatin-eligible patients diagnosed with locally advanced or metastatic urothelial cancer (mUC)...
Japan Approves Enfortumab Vedotin for the Treatment of Advanced Urothelial Cancer
Japan's Ministry of Health, Labour and Welfare (MHLW) has approved enfortumab vedotin (Padcev®; Astellas Pharma and Seagen) for the treatment of radically unresectable urothelial...
Enfortumab Vedotin Receives Regular Approval and an Expanded Indication for Locally...
The U.S. Food and Drug Administration (FDA) has granted regular approval for enfortumab vedotin-ejfv (Padcev®; Astellas Pharma and Seagen) while, at the same time,...
Sacituzumab Govitecan Receives Accelerated Approval for Advanced or Metastatic Urothelial Cancer...
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Gilead Sciences* Sacituzumab Govitecan** (Trodelvy®) for use in adult patients with locally...
U.S. FDA Grants Breakthrough Therapy Designation for Disitamab Vedotin in Urothelial...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for disitamab vedotin (previously known as RC48), for the second-line treatment of...
Study Meets Primary Endpoint: Enfortumab Vedotin Significantly Improves Overall Survival in...
A phase III trial of enfortumab vedotin (enfortumab vedotin-ejfv; Padcev®; Seattle Genetics/Astellas) met its primary endpoint of overall survival (OS) compared to chemotherapy.
Globally, approximately...
Updated Results from Trial Shows Enfortumab Vedotin + Pembrolizumab to Shrink...
Updated findings from EV-103, a phase Ib/II clinical trials of enfortumab vedotin* (Padcev™; Astellas Pharma/Seattle Genetics) in combination with pembrolizumab (Keytruda®; Merck Sharp &...
Enfortumab Vedotin + Pembrolizumab to be Evaluated in Phase III...
Enfortumab vedotin (also known as AGS-22ME; Seattle Genetics/Astellas), an antibody-drug conjugate (ADC), will be evaluated in a phase III clinical trial in combination with...
Astellas and Seattle Genetics file BLA for Enfortumab Vedotin
Japanese drugmaker Astellas Pharma and Seattle Genetics confirmed the submission of a Biologics License Application (BLA) for accelerated approval to the U.S. Food and...
