An additional Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the US Food and Drug Administration.
Under development by UK pharma major AstraZeneca (LSE: AZN) and Japanese partner Daiichi Sankyo’s (TYO: 4568), the new Dato-DXd BLA is intended for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. The deal between the companies provides for the Japanese firm to earn nearly $7 billion from AstraZeneca.
The Prescription Drug User Fee Act date, the FDA action date for its regulatory decision, is scheduled during the first quarter of 2025.
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