The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee has voted in favor of approving one cancer drug from Japanese drugmaker Daiichi Sankyo (TYO: 4568) but voted against another one.
There were 12 votes in favor and three against pexidartinib, and if the agency follows the panel’s recommendation, then it will become the first and only approved therapy for tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations, and not amenable to improvement with surgery.
The votes suggest that the benefit outweighs the risks in the treatment of adult patients with symptomatic TGCT, though the FDA will make its final decision by early August, having granted pexidartinib a priority review voucher.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze