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

Amylyx’s Late-Stage Drug Fails In PSP, But Focus Remains On Avexitide

 
• By Jessica Merrill

The drug that was once commercialized as Relyvrio for ALS failed to show a benefit in adults with progressive supranuclear palsy.

Norway’s Nykode Upbeat About Cancer Vaccines After Tough Year

 
• By Kevin Grogan

The firm is concentrating on its Keytruda combo for head and neck cancer after being abandoned by Roche and boardroom battles.

Lilly’s Orforglipron Makes Strong Showing In Diabetic Obesity Population

 
• By Alaric DeArment

The drugmaker announced topline results from the Phase III ATTAIN-2 trial in overweight/obese patients with type 2 diabetes and plans to file for approval.

Regeneron Plans To File Cemdisiran For gMG But Will Face Tough Market

 
• By Jessica Merrill

Head of hematology clinical development Andres Sirulnik talked to Scrip about the positive Phase III results for the siRNA medicine.

More from R&D

Lilly’s Orforglipron Makes Strong Showing In Diabetic Obesity Population

 
• By Alaric DeArment

The drugmaker announced topline results from the Phase III ATTAIN-2 trial in overweight/obese patients with type 2 diabetes and plans to file for approval.

Regeneron Plans To File Cemdisiran For gMG But Will Face Tough Market

 
• By Jessica Merrill

Head of hematology clinical development Andres Sirulnik talked to Scrip about the positive Phase III results for the siRNA medicine.

Novartis Signs Up For BioArctic Blood-Brain Barrier Tech

 
• By Kevin Grogan

The Swiss giant is paying $30m upfront for rights to the Swedish firm’s BrainTransporter technology, its second brain-barrier breaching deal in as many months.