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Bavencio (avelumab)

What is Bavencio?

Bavencio ® (avelumab) is an immunotherapy drug that was approved by the U. S. Food and Drug Administration (FDA) for treating advanced or metastatic bladder cancer in 2017.1 Bavencio is delivered through an intravenous (IV) infusion. Most patients receive treatment with Bavencio every two weeks and each infusion lasts for about an hour.

How does it work?

Like other immunotherapy drugs, Bavencio works by helping a patient’s immune system work more effectively to fight cancer cells.1,2 The immune system is a collection of organs and cells that work together to protect the body from diseases and infections, including cancer cells.

Bavencio is called a PD-L1 inhibitor, which is a new type of immunotherapy treatment for advanced or metastatic bladder cancer as well as other cancers. Bavencio helps block the PD-L1 protein, which can enable cancer cells to disguise themselves from the immune system’s protective functions. When PD-L1 proteins enable cancer cells to hide from the immune system, the cancer cells can grow more easily because they are not being targeted and attacked by immune system cells. By blocking the disguising function of the PD-L1 proteins, PD-L1 inhibitors, such as Bavencio can help a patient’s immune system to fight the cancer cells more effectively.

During the clinical trials to test the effectiveness of treatment with Bavencio in patients with advanced or metastatic bladder cancer, some patients’ tumors became smaller after treatment.

Who can receive Bavencio?

Bavencio is only prescribed for patients with advanced or metastatic bladder cancer that that has spread beyond the bladder and/or to other parts of the body.1 Healthcare providers can provide more information about whether treatment with Bavencio may be appropriate for a specific patient’s bladder cancer. However, it is generally used to treat patients who have already tried treatment with chemotherapy that contains platinum, but the chemotherapy did not work or is no longer working.

Because Bavencio can cause some very serious side effects, healthcare providers need to know if a patient has certain types of health conditions before prescribing Bavencio. These health conditions include:

  • Immune system problems, such as Crohn’s disease or ulcerative colitis
  • Having had an organ transplant
  • Lung or breathing problems
  • Liver or kidney problems
  • Endocrine disorders such as diabetes or thyroid disorders

Women who are pregnant, planning to become pregnant, or breastfeeding must tell their healthcare providers because treatment with Bavencio can cause very serious side effects. Women should use contraception during treatment and for one month after the last dose of Bavencio.

What are the possible side effects?

In people treated with Bavencio for advanced or metastatic bladder cancer, the most commonly reported side effects are 1:

Bavencio can affect healthy cells as well as cancer cells. This can cause some very serious side effects in some patients. It is important to speak with your healthcare provider about all of the possible benefits and serious side effects that treatment with Bavencio can cause. Before starting treatment, your healthcare provider will also discuss the symptoms of the severe side effects so that you can recognize them and seek treatment as early as possible. These serious side effects can include:

  • Lung problems
  • Liver problems
  • Intestinal problems
  • Hormone gland problems
  • Kidney problems
  • Problems in other organs
  • Severe infusion reactions

If you experience any of the symptoms of severe side effects, let your healthcare provider know immediately. Immediate treatment can potentially help keep the side effects from getting worse. This is not an exhaustive list of all potential side effects of Bavencio. Talk to your healthcare provider or pharmacist for further information.

Written by Anna Nicholson | Last review date: December 2018.
  1. BAVENCIO Prescribing Information. EMD Serono, 2017.
  2. Bavencio Highlights of Prescribing Information. FDA label. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761078s000lbl.pdf. Accessed September 2017.