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Does Entyvio increase the risk of cancer?

Medically reviewed by Sally Chao, MD. Last updated on Aug 26, 2024.

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.

Read next

How much does Entyvio cost per month?

The cash price for Entyvio is $9,135 for a 300 mg powder for intravenous (IV) injection, using an online coupon, but most people do not pay this amount. After your initial 2 injections in the first month, IV Enytvio is normally given every 8 weeks starting at week 6. It also comes as a subcutaneous (under the skin) injection that is given every 2 weeks. Continue reading

Is Entyvio an immunosuppressant or a biologic?

Entyvio (generic name: vedolizumab) is a biologic therapy approved for the treatment of ulcerative colitis and Crohn’s disease. Entyvio has no known systemic (whole body) immunosuppressive effects, but still has a risk of infections. Continue reading

How long does it take Entyvio to start working?

Entyvio may reduce your gut inflammation in about 6 weeks. Over time, Entyvio can help you to have fewer symptoms, go into remission, and reduce or stop the use of corticosteroids. In remission, your symptoms such as stomach pain and cramping, diarrhea and fatigue will go away. Continue reading

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