Omalizumab therapy is not associated with an increased risk of malignancy

Omalizumab (Xolair) is a monoclonal antibody made by Genentech/Novartis. In more detail, it is a recombinant DNA-derived humanized IgG1k monoclonal antibody that selectively binds to human immunoglobulin E (IgE). Omalizumab binds to Cε3 region of IgE.

Omalizumab is approved by the FDA for treatment of moderate-to-severe allergic asthma and chronic urticaria.

The Epidemiologic Study of Xolair (omalizumab): Evaluating Clinical Effectiveness and Long-term Safety in Patients with Moderate-to-Severe Asthma (EXCELS) assessed the long-term safety of omalizumab in a clinical practice setting as part of a phase IV FDA postmarketing commitment.

EXCELS was a prospective observational cohort study in patients aged 12 years or older with moderate-to-severe allergic asthma. There were 2 cohorts: omalizumab (taking omalizumab at baseline) and nonomalizumab (no history of omalizumab treatment). Median follow-up was 5 years for both cohorts. Crude malignancy rates were similar in the omalizumab and nonomalizumab cohorts, with a rate ratio of 0.84. Hazard ratio (omalizumab vs nonomalizumab) was 1.09.

Omalizumab therapy is not associated with an increased risk of malignancy.

However, asthma drug Xolair is associated with a higher risk of heart attack, mini-stroke, chest pain, blood clots - FDA announced in September 2014:


Incidence of malignancy in patients with moderate-to-severe asthma treated with or without omalizumab. Aidan Long et al. Journal of Allergy and Clinical Immunology
Volume 134, Issue 3, Pages 560–567.e4, September 2014

Images: Mechanisms of action of omalizumab. JACI, 02/2008.

Image source: Wikipedia, public domain.

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