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Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First...

Enfortumab vedotin + Pembrolizumab Approved by US FDA as the First and Only ADC + PD-1 Combination to Treat Advanced Bladder Cancer

Priority Review for Supplemental Biologics License Application of Enfortumab Vedotin +...

The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for priority review for enfortumab vedotin-ejfv (Padcev® ; Astellas/Seagen with pembrolizumab (Keytryuda® ( Merck & Co; Merck Sharp & Dohme/MSD) as a combination therapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), a form of bladder cancer that has spread to surrounding organs or muscles, or other parts of the body.
Exhibition booth Seattle Genetics - ASCO 2019 | Courtsey: Emila Duaerte / Sunvalley Communication

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...

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...

IND for RemeGen’s Disitamab Vedotin Marks Important Milestone for the Company’s...

The U.S. Food and Drug Administration (FDA) has cleared an Investigational New Drug (IND) application allowing Yantai (Shandong Province; China) -based biopharmaceutical company RemeGen...

Accelerated Approval for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial...

The U.S. Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv (Padcev™; Astellas Pharma / Seattle Genetics)* for the treatment of adult...

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...
General images of ESMO 2019 Congress being held in Barcelona, Spain, September 27 - October 1, 2019. Courtesy European Society for Medical Oncology (ESMO). Used with Permission.

ESMO 2019: Sacituzumab Govitecan Achieves 29 Percent ORR in Advanced Urothelial...

Interim data from a 100-patient cohort of cisplatin-eligible patients participating in the TROPHY-U-01, an international, multi-center, open-label, phase II study, in patients with metastatic...

Breakthrough Therapy Designation Granted for Enfortumab Vedotin in Locally Advanced or...

This week the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate or ADC, for patients with...

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