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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.

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)...
Astellas Pharma. Exhibition booth during the 2019 annual meeting of the American Society of Medical Oncology (ASCO).

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...
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...

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 &...

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