Janssen and Pharmacyclics submit EMA application to expand indication for Imbruvica
US health care giant Johnson & Johnson’s (NYSE: JNJ) Belgium-based subsidiary Janssen-Cilag International has submitted a Type II variation application to the European Medicines Agency to vary the marketing authorization for Imbruvica (ibrutinib), to include a new therapeutic indication for the treatment of adult patients with Waldenström’s macroglobulinemia (WM).
WM is a rare type of B-cell lymphoma. If approved, this latest regulatory submission will expand the indications for Imbruvica to a third type of blood cancer. Imbruvica is a first-in-class, once-daily, oral Bruton’s tyrosine kinase (BTK) inhibitor.
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
More Features in Pharmaceutical
| Headless Content Management with Blaze