Ipilimumab Risk Strategy Released by FDA

Emma Hitt, PhD

April 06, 2011

April 6, 2011 — A new risk evaluation and mitigation strategy (REMS) for ipilimumab (Yervoy, Bristol-Myers Squibb) includes recommendations for healthcare professionals to ensure that the benefits of ipilimumab outweigh the immune-associated adverse events.

The US Food and Drug Administration (FDA) issued a safety alert today from MedWatch, the FDA's safety information and adverse event reporting program. The REMS was developed by Bristol-Myers Squibb in collaboration with the FDA.


The FDA approved ipilimumab in March 2011 for use as monotherapy to treat stage III/IV metastatic melanoma. Ipilimumab is a fully human monoclonal antibody (IgG1) that blocks cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) to promote antitumor immunity. In a phase 3 clinical trial, published in 2010 (N Engl J Med. 2010:363;711-723), ipilimumab was reported to significantly improve the overall survival in patients with previously treated metastatic melanoma.

The prescribing information includes a boxed warning informing healthcare professionals that ipilimumab can cause severe and fatal immune-mediated adverse reactions. The most common immune-mediated adverse reactions include enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), and endocrinopathy.

Clinicians are advised to discontinue the use of ipilimumab and start systemic high-dose corticosteroid therapy in patients with immune-mediated reactions. Patients should be assessed for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy. Liver and thyroid function should be evaluated at baseline and before each dose.

The REMS recommends that healthcare providers read the boxed warning and full prescribing information for a complete description of the risks associated with ipilimumab and their management. Clinicians should also discuss these risks with patients and their caregivers.

Healthcare professionals and patients should report adverse events or product quality problems related to the use of ipilimumab to MedWatch by telephone at 1-800-332-1088, by fax at 1-800-FDA-0178, online at https://www.fda.gov/MedWatch/report.htm, or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20857.


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