Pink Sheet 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

After ODAC: The State Of Accelerated Approval At The US FDA

Executive Summary

US FDA’s Accelerated Approval process has always been a deceptively simple idea. After a three-day public review of ‘dangling’ applications, the underlying complexity remains.

You may also be interested in...



Pazdurcanumab: US FDA’s Top Cancer Official Weighs In On That Big Neurology Approval

Richard Pazdur is eager for a conversation about how to improve the Accelerated Approval pathway. The OCE director welcomes aducanumab’s approval – both on its own terms but also as an opportunity to broaden the discussion.

ODAC Report Card: Six Takeaways From Accelerated Approval Reviews Of Checkpoint Inhibitors

US FDA’s expedited pathway remains alive and well in oncology, but ‘dangling’ indications may be subject to more regular public scrutiny going forward; negative votes for two of six indications reflected the influence of Oncology Center of Excellence director Richard Pazdur.

FDA Panel Okays Keytruda’s Hepatocellular Carcinoma Indication, But Splits On Opdivo

In 5-4 vote, US FDA advisory committee recommends withdrawal of Opdivo’s accelerated approval for second-line treatment of HCC while unanimously supporting the indication in Keytruda pending outcome of ongoing studies.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS144274

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