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Does Entyvio increase the risk of cancer?

Medically reviewed by Kristianne Hannemann, PharmD. Last updated on March 26, 2025.

Official answer

by Drugs.com

Current research suggests that Entyvio (vedolizumab) does not increase cancer risk. Studies show that the number of people who develop cancer while taking Entyvio is similar to the expected rate in the general population.

Cancer Risk and Inflammatory Bowel Disease (IBD)

Entyvio treats Crohn’s disease and ulcerative colitis, conditions that already carry a higher-than-average cancer risk. When evaluating Entyvio’s potential risk, researchers compare it to the pre-existing cancer risk among patients with IBD.

Clinical Trial Data and Long-term Studies

  • Initial clinical trials: Among 1,434 people taking Entyvio, 0.4% (6 patients) developed cancer, compared to 0.3% (1 of 297) in the placebo group.
  • Long-term studies: Since its approval in 2014, continued research has not found a link between Entyvio and an increased cancer risk.

Conclusion

The available data indicate that Entyvio is not associated with higher cancer rates. However, ongoing monitoring and consultation with a healthcare provider are recommended for long-term safety.

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.
  6. Singh S, Heien HC, Sangaralingham L, Shah ND, Sandborn WJ. Risk of Malignancy with Vedolizumab Versus Tumor Necrosis Factor-α Antagonists in Patients with Inflammatory Bowel Diseases. Dig Dis Sci. 2022 Jun;67(6):2510-2516. doi: 10.1007/s10620-021-07073-4. Epub 2021 Jun 3. PMID: 34085174; PMCID: PMC8933138.

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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