Additional BLA under review in USA for datopotamab deruxtecan

2 April 2024
astrazeneca_big-2

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 account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
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

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology