European Commission expands license for Janssen's Zytiga

21 November 2017

The European Commission has given its backing to broaden the existing marketing authorization for Zytiga (abiraterone acetate) plus prednisone/prednisolone to include an earlier stage of metastatic prostate cancer than its current indications.

The expanded approval was granted to Janssen-Cilag International, a subsidiary of US healthcare giant Johnson & Johnson (NYSE: JNJ).

The European Commission has already approved the combination of Zytiga plus prednisone/prednisolone as treatment for adult men with mCRPC who have no or mild symptoms and failed to respond to ADT, and for whom chemotherapy is not indicated. The drug is also approved for adults whose disease has progressed or who received a Taxotere (docetaxel)-based chemotherapy regimen.

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.

Try before you buy

Free

7 day trial access

Take a Free Trial

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

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