Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

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

Executive Summary

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.

You may also be interested in...



Enfortumab Progresses As US Accelerated Approval Eyed In Urothelial Cancer

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.

Keeping Track: Keytruda Adds Two New Uses, Furoscix ‘Patch Pump’ Gets A CRL, And Nightstar Nabs An RMAT

The latest drug development news and highlights from our US FDA Performance Tracker.

What We Talk About When We Talk About Confirmatory Evidence

Meaning of 'confirmatory evidence' becomes review issue in some of US FDA's most difficult choices: when a drug for a significant unmet medical need is supported by a single inadequate – but not failed – clinical trial. Neurology division director Dunn and review team leader Marler explain their interpretations in Ocrevus review memos.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

PS123326

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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