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Does Entyvio increase the risk of cancer?

Medically reviewed by Sally Chao, MD. Last updated on Sep 3, 2021.

Official answer

by Drugs.com

Entyvio (vedolizumab) does not seem to increase your risk of developing cancer. Research suggests that the number of people who develop cancer while taking Entyvio is similar to the number of people expected to develop cancer if they were not taking the drug.

Entyvio is used to control inflammation and symptoms of Crohn’s disease and ulcerative colitis, inflammatory bowel diseases that come with a higher-than-average risk of cancer. When assessing the cancer risk associated with Entyvio, researchers must compare it to the already elevated risk of cancer among the patient population.

In the initial clinical trials testing the safety and efficacy of Entyvio, a similar percentage of people taking Entyvio or placebo developed cancer—six of 1,434 (0.4%) of the people taking Entyvio developed cancer, while one of 297 (0.3%) of those taking a placebo developed cancer.

Since the drug’s approval in 2014, the outcomes among patients taking Entyvio have been followed and analyzed extensively. The lack of association between Entyvio and cancer has continued to be proven, even with longer-term use.

All together, the data reflect that Entyvio is not associated with higher rates of cancer. In some analyses, the drug even seemed to come with a lower risk of cancer in the colon and rectum.

References
  1. Card T, Ungaro R, Bhayat F, Blake A, et al. Vedolizumab use is not associated with increased malignancy incidence: GEMINI LTS study results and post-marketing data. Aliment Pharmacol Ther. 2020;51(1):149-157. doi: 10.1111/apt.15538.
  2. U.S. Food and Drug Administration (FDA). ENTYVIO (vedolizumab) for injection, for intravenous use. Last updated May 2014. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125476s000lbl.pdf. [Accessed August 26, 2021].
  3. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Definition & Facts for Crohn’s Disease. Last updated September 2017. Available at: https://www.niddk.nih.gov/health-information/digestive-diseases/crohns-disease/definition-facts. [Accessed August 26, 2021].
  4. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Definition & Facts for Ulcerative Colitis. Last updated September 2020. Available at: https://www.niddk.nih.gov/health-information/digestive-diseases/ulcerative-colitis/definition-facts. [Accessed August 26, 2021].
  5. Loftus EV Jr, Feagan BG, Panaccione R, et al. Long-term safety of vedolizumab for inflammatory bowel disease. Aliment Pharmacol Ther. 2020;52(8):1353-1365. doi: 10.1111/apt.16060.

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