International clinical trials, including trials in Canada, are being stopped due to serious adverse events with the drug Zydelig, in combination with other cancer drugs

Starting date:

March 17, 2016

Type of communication:

Information Update

Subcategory:

Drugs

Source of recall:

Health Canada

Identification number:

RA-57590

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Issue

OTTAWA – Health Canada is informing Canadians and health care professionals of four Canadian clinical trials, involving the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines, being stopped after reports of an increased rate of serious adverse events, including deaths. Three additional trials will be amended by implementing added measures to protect participants.

These studies investigated the use of Zydelig in patients with different disease characteristics or with different drug combinations than those for which Zydelig is currently approved for use in Canada. 

Health Canada is working with the sponsors of these clinical trials to help ensure they notify all Canadian participants in its trials. The trial sponsor has communicated the new safety issues to Canadian trial site investigators. Patients enrolled in clinical trials using Zydelig should speak with their physician.

Health Canada is also conducting a review of the drug Zydelig and will take appropriate next steps as needed.

This updated information only applies to changes in the risk profile of Zydelig in clinical trial situations. Patients who are using this drug for treatment of illness outside of a clinical trial setting should discuss any concerns with their health care provider before making any changes to their use of medications.

Zydelig was approved in Canada in April 2015 to treat a type of blood cancer called relapsed chronic lymphocytic leukemia (blood and bone marrow disease). It is also used by patients with follicular lymphoma who have previously received other therapies.

The Canadian labelling for Zydelig contains Warnings and Precautions regarding the risk of decrease in certain white blood cells (neutrophils) and recommends monitoring of blood counts, including neutrophil counts. Certain types of infections are also noted under Adverse Drug Reaction section of the product monograph for Zydelig.

Health Canada is advising patients to speak with their doctor if they have questions or concerns about Zydelig. Health-care professionals and patients are also encouraged to report adverse events involving Zydelig to Health Canada.

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

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