Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Enfortumab Progresses As US Accelerated Approval Eyed In Urothelial Cancer

Executive Summary

Astellas and Seattle Genetics now expect key top-line data on their antibody-drug conjugate in urothelial cancer in the first half of next year, as pivotal trials in support of a planned US accelerated approval progress.

You may also be interested in...



ECHELON-2 Ushers In Another New Adcetris Indication For Seattle Genetics

The combination of Adcetris with chemotherapy improved progression-free and overall survival in peripheral T-cell lymphoma. Filing is expected soon, and approval will help the product reach blockbuster status.

Keytruda's Broad Confirmatory Trials Suggest Evolution Of US FDA’s Accelerated Approval Model

FDA’s most recent accelerated approvals for Merck’s Keytruda call for confirmatory trials in a broader patient population than the approved indications, in the latest example of FDA’s growing comfort with multi-purpose confirmatory trials in the PD-1/PD-L1 inhibitor space.

Breakthrough Status Arrives Late In Development Of Yervoy+Opdivo, Enfortumab Vedotin And Pedmark

US FDA's latest BTD awards go to Seattle Genetics and Astellas' antibody-drug conjugate for immunotherapy-experienced urothelial cancer, Fennec's supportive care product to reduce cisplatin ototoxicity in pediatric cancer patients, and Bristol's double immunotherapy combo in MSI-H colorectal cancer.

Topics

Related Companies

UsernamePublicRestriction

Register

SC123384

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel