Health Canada issues safety warning on Zydelig

4 May 2016

Medicines regulator Health Canada has issued a health warning on US biotech major Gilead Sciences’ (Nasdaq: GILD) blood cancer drug Zydelig (idelalisib).

Key messages from the agency were as follows:

Decreased overall survival and an increased risk of serious adverse events (mostly infections) were observed in patients receiving Zydelig compared to the control groups in clinical trials.
These trials evaluated the addition of Zydelig to standard therapies for first line treatment of chronic lymphocytic leukemia (CLL) and early line treatment of relapsed indolent non-Hodgkin’s lymphoma (iNHL).
Zydelig should not be used for first line treatment of CLL.
The Canadian Product Monograph for Zydelig will be updated to reflect this new information.

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