No new indication for Celgene
Celgene Europe, the EU arm of the US drugmaker, has announced the withdrawal of its centralized marketing authorization application for an additional indication of its Revlimid (lenalidomide) to the European Medicines Agency (EMEA).
The decision follows the EMEA Committee for Medicinal Products for Human Use's (CHMP) recommendation for refusal of the application (Marketletter February 4). Celgene has decided to withdraw before the decision is formalized.
The CHMP cited concerns over how a single-arm, Phase II study for the application was carried out as the reason behind the refusal. On its web site, the EMEA said the Committee had concerns regarding the way the results were recorded and a lack of adequate safety profiling as the drug was not compared to any other treatment.
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
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze