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

Phase III Data ENLIVEN Pexidartinib’s Prospects But Liver Tox An Issue?

Executive Summary

Phase III results for Daiichi Sankyo’s pexidartinib presented at ASCO provide new hope in a rare tumor type with no approved therapies, but hepatic toxicity also emerged as a safety issue in the study.

You may also be interested in...



Defining REMS Success An Unanswered Question For Daiichi's Pexidartinib

US FDA still deliberating on how best to measure success of the liver safety program for Daiichi's TGCT treatment, but REMS will probably assess both process and outcomes. 

Daiichi's Pexidartinib Likely Needs REMS For Liver Safety Concerns

REMS with provider and pharmacy certification could help address hepatotoxicity worries for the tenosynovial giant cell tumor treatment, but Daiichi likely also will face clinical benefit questions during advisory committee review.

Coronavirus Update: Large Study Boosts Case For Vaccine Mixing

Results from a large Swedish study provide further evidence that mixing different COVID-19 vaccines boosts effectiveness. Meanwhile, Japan plans new funding to support the home-grown development of coronavirus and other vaccines. 

Topics

Related Companies

UsernamePublicRestriction

Register

SC123209

Ask The Analyst

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

Thank you for submitting your question. We will respond to you within 2 business days. 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