Summary Safety Review - GILENYA (fingolimod) - Assessing the Risk of the Abnormal Tissue Growth (Cancer)

Review decision

A Summary Safety Review complements other safety related information to help Canadians make informed decisions about their use of health products. Each summary outlines what was assessed in Health Canada’s review, what was found and what action was taken by Health Canada, if any.


Issued: 2015-09-14

Product

GILENYA (fingolimod)

Potential Safety Issue

Abnormal tissue growth (Neoplasms)

Key Messages

  • Gilenya (fingolimod) is used to treat multiple sclerosis, a condition that results in the damage of the nervous system, leading to physical and mental disability. It is specifically used in patients who have had a poor response to, or are unable to tolerate one or more therapies for multiple sclerosis.
  • The potential link between the use of Gilenya and abnormal tissue growth (neoplasms) was identified during a Health Canada review of safety information obtained from the manufacturer.
  • Health Canada's safety review showed evidence of a potential link between the use of Gilenya and an increased risk of lymphomas and other malignant cancers, particularly of the skin. The Canadian product monograph for Gilenya has been updated to include this information. Health Canada has requested additional safety information from the manufacturer and will continue to monitor this issue.

Overview

A safety review was done to evaluate a potential link between Gilenya (fingolimod) and abnormal tissue growth (neoplasms). This issue was identified through a Health Canada review of safety information obtained by the manufacturer. When a neoplasm forms a mass, it can commonly be referred to as a tumour. Tumours can be further divided into those that are cancerous (malignant) and those that are non-cancerous (benign).

Use in Canada

  • Gilenya is a medicine used to treat multiple sclerosis, a condition that results in the damage of the nervous system. Gilenya reduces the frequency of signs and symptoms of multiple sclerosis by delaying the progression of physical disability. The most common type of multiple sclerosis is one where symptoms of an attack flare up and are then followed by a time of recovery (relapsing-remitting multiple sclerosis).
  • Gilenya is recommended in patients who have had a poor response to, or are unable to tolerate one or more therapies for multiple sclerosis.
  • Gilenya was first marketed in Canada in March 2011.

Safety Review Findings

  • At the time of the review, the Canada Vigilancea program received 16 reports of neoplasms linked to Gilenya. There were no life-threatening events or deaths reported, and no more than two cases were reported for any particular type of cancer, including skin cancer and a type of blood cancer (lymphoma).
  • The World Health Organization's database presented 62 cases of skin cancer at the time of the review. Eight or fewer cases of each remaining non-skin cancer were reported, with the exception of breast cancer where there were 30 cases.
  • A review of the scientific and medical literature identified two published patient medical reports (case reports), three medical research studies on human participants (clinical trials), and four safety reviews that describe cases of neoplasms in patients treated with Gilenya. In two of the clinical trials, participants receiving Gilenya had a higher occurrence of skin cancers than those who did not.
  • Numerous patient medical reports received from the manufacturer link skin cancer to Gilenya since it was first approved for sale. In addition, reports of skin cancer have increased recently in patients treated with Gilenya.
  • Patients receiving medicines that suppress the immune system, like Gilenya, are known to have an increased risk of lymphomas and other malignant cancers, particularly of the skin.
  • At the time of the review, the Canadian product monograph already labeled for the risk of lymphoma with "uncertain" relationship to Gilenya, but it did not label for any other neoplasms.

Conclusions and actions

  • Health Canada's safety review showed evidence of a potential link between Gilenya and the increased risk of lymphomas and other malignant cancers, particularly of the skin.
  • The Canadian product monograph for Gilenya has been updated to include the risk of lymphomas and other malignant cancers, particularly of the skin.
  • Side effects like neoplasms are rare and could take a long time to develop or be detected. Therefore, additional safety information from the manufacturer of Gilenya about the risk of neoplasms has been requested by Health Canada. Furthermore, Health Canada will continue to monitor side effect information involving Gilenya, as it does for all health products on the Canadian market, to identify and assess potential harms. Health Canada will take appropriate and timely action if and when any new health risks are identified.

Additional information

The analysis that was carried out for this safety review took into consideration information from scientific and medical literature, Canadian and international adverse reaction reports as well as what is known about the use of this drug in Canada and internationally.

For additional information, contact the Marketed Health Products Directorate.

Footnotes

  1. Canadian reports can be accessed through the Canada Vigilance Adverse Reaction Database.

Report a problem or mistake on this page
Please select all that apply:
Date modified: