1. Scrip
  2. >>R&D
  3. >>Clinical Trials

New Data Set Up Padcev For Potential Expanded Use

Regulatory Discussions Planned

 
• By Ian Haydock

Positive top-line data from a second pivotal trial cohort are set to support regulatory filings for the ADC in patients whose cancer has progressed after immunotherapy but are ineligible for cisplatin.

Bladder cancer medical concept as an anatomical organ symbol with microscopic malignant cells spreading in the human body as a health care 3D illustration.
Padcev Moves Forward In Bladder Cancer • Source: Shutterstock

Astellas Pharma, Inc. and Seagen Inc. (formerly Seattle Genetics) have announced positive top-line results from a second cohort of patients in a pivotal Phase II trial with Padcev (enfortumab vedotin) in advanced urothelial cancer, paving the way for a planned US filing for a supplemental indication.

The EV-201 trial found durable responses with monotherapy in patients with locally advanced or metastatic disease previously treated with an...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

More from R&D

Pipeline Watch: Eight Approvals And Ten Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

UroGen Gets A First-Ever Bladder Cancer Approval Despite US FDA AdComm ‘No’ Vote

 
• By Joseph Haas

UroGen’s Zusduri was approved despite an advisory committee vote recommending against it in May. It is the first approved drug for a type of recurring bladder cancer.

UCB Follows Fellow European Pharmas With Major US Investment

 
• By Kevin Grogan

The Belgian drugmaker is boosting its biologics capacity over the pond.