AstraZeneca withdraws EU submission for lung cancer drug
AstraZeneca (LSE: AZN) and development partner Daiichi Sankyo (TYO: 4568) have withdrawn a marketing authorization application for datopotamab deruxtecan (Dato-DXd) in lung cancer.
The firms had submitted for approval to market the antibody-drug conjugate (ADC) for the treatment of a relatively broad population of non-squamous non-small cell lung cancer (NSCLC) patients, but reversed course after feedback from the agency’s scientific panel.
The application was based on results from the Phase III TROPION-Lung01 trial, which showed a progression-free survival benefit for Dato-DXd over chemotherapy in patients with non-squamous NSCLC. However, the study failed to demonstrate a statistically-significant overall survival advantage, a key benchmark for regulatory approval.
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
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- 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
More on this story...
Today's issue
Company Spotlight
More Features in Biotechnology
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze