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
UsernamePublicRestriction

US FDA’s Pediatric Cancer Targets List Spurs Questions On Breadth, Prioritization

Executive Summary

Initial draft list of molecular target candidates has industry, investigators and patient advocates asking how the agency intends to prioritize targets and same-in-class molecules for pediatric studies, and how frequently it will update the list; industry representatives divided as to whether ‘broader is better’ when it comes to the target list.

You may also be interested in...



Pediatric Cancer: US FDA Will Take ‘Rational’ Approach To Requiring Combination Studies

Agency urged to prioritize studies based on strength of preclinical and adult data, and good mechanistic understanding of how multiple therapies are expected to work together; new pediatric study requirements for molecularly targeted agents take effect in August 2020.

Oncology Sponsors Getting A Jump On Pediatric Study Requirements, US FDA Says

Beginning in August 2020, applications for some novel cancer drugs and biologics will have to include reports on molecularly targeted pediatric investigations; agency is already working with sponsors on pediatric study development plans and expects to issue two draft guidances soon.

Pediatric Cancer Studies: US FDA’s Molecular Target Lists Face Panel Vetting

In addition to reviewing proposed lists of targets for relevance to pediatric cancer, advisory committee will discuss possible criteria for prioritizing same-in-class agents for evaluation and ways to promote international collaboration and global development; proposed list of substantially relevant targets is growing.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM013164

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