Tag: urothelial cancer

China Approves Combination of Enfortumab Vedotin + Pembrolizumab for the Treatment of Advanced Bladder Cancer

During the upcoming annual meeting of the European Society for Medical Oncology (ESMO), being held in Barcelona, September 13-17, 2024, expect presentations to include new data on advances in the treatment of hard-to-treat cancers using approved and investigational agents, including enfortumab vedotin (Padcev™; Astellas/Pfizer/Seagen), Zolbetuximab (previously known as IMAB362), Enzalutamide (Xtandi®; Astellas/Pfizer) and various pipeline products.

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

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.

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,...

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...

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...

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...

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 (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...