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FDA Approves Brukinsa for Treatment of Mantle Cell Lymphoma

Recently, the U.S. Food and Drug Administration (FDA) approved BrukinsaTM (zanubrutinib) to treat mantle cell lymphoma. Mantle cell lymphoma is a rare type of non-Hodgkin lymphoma (NHL), a blood cancer. It arises from the B-cell lymphocytes in the body. B-cell lymphocytes are a type of white blood cell that make antibodies. Antibodies are proteins that help fight infection. About 3-10 percent of all NHL cases are mantle cell lymphoma.1

The FDA approved Brukinsa for use by adults with mantle cell lymphoma who have tried at least 1 other treatment option. Mantle cell lymphoma often responds to an initial treatment and goes into remission. However, over time, a person can relapse and a new treatment option is needed. This is an example of a situation in which Brukinsa might be helpful.

Brukinsa may also be used when mantle cell lymphoma does not respond to treatment at all. This is called refractory lymphoma. The approval of Brukinsa means another treatment option could extend life expectancy or improve the chances of treatment response.

Brukinsa speeds to market

The FDA approved Brukinsa through several unique programs. Brukinsa received accelerated approval. This means it was approved quickly after the early stages of research because it is thought to fill an unmet need for a serious condition. It was also given breakthrough therapy and orphan drug designations. These labels allowed Brukinsa to receive a speedier approval because early research showed that it may be more effective than currently available drugs, and it treats a rare health condition. Brukinsa was approved faster than usual since it showed strong potential for a condition in need of new treatment options.

Brukinsa’s accelerated approval was made based on the results of 2 small clinical trials. One trial included 86 people with mantle cell lymphoma and the second had 32 people. Tumors shrank in 84 percent of participants in each trial. The trials also measured the time between first response and progression or relapse.

This is called the median duration of response, and is a measure of how long a treatment’s effects might last. The average length of response was 19.5 months for the first trial and 18.5 months for the second. These results suggest that Brukinsa may provide tumor shrinkage and more months until the cancer progresses.

How does Brukinsa work?

Brukinsa is a receptor tyrosine kinase inhibitor, a type of targeted therapy. This means it blocks a receptor on the outside of our cells called a tyrosine kinase. B-cells have these receptors on them. When B-cells get a signal through this receptor, it tells them to grow. This process can be altered when a person has mantle cell lymphoma, leading to unregulated growth, or cancer. By blocking this receptor with a drug like Brukinsa, cancerous cell growth may be slowed or stopped.

What are the side effects of Brukinsa?

The most common side effects of Brukinsa are low platelet counts (cells that help blood clot); low neutrophil and other white blood cell counts (cells that help fight infection); and low hemoglobin (a protein that helps our red blood cells deliver oxygen throughout the body). Other common side effects were diarrhea, bruising, cough, rash, and upper respiratory infection.

People taking Brukinsa may need to be followed for bleeding, changes in the way their heart beats (arrhythmias), and signs of infection. Other cancers may occur when taking Brukinsa, including skin cancers. Because of this, people taking Brukinsa should practice good sun protection when taking the drug.

Pregnant women or women who are breastfeeding should not take Brukinsa. Your doctor can help you decide if Brukinsa is a treatment option for you. Brukinsa is made by BeiGene USA Inc.1,2

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. FDA Approves Therapy to Treat Patients with Relapsed and Refractory Mantle Cell Lymphoma Supported by Clinical Trial Results Showing High Response Rate of Tumor Shrinkage. United States Food and Drug Administration. Available at: Accessed 11/18/2019.
  2. Brukinsa Prescribing Information. United States Food and Drug Administration. Available at: Accessed 11/18/2019.


  • Ann Harper moderator
    2 months ago

    Thank you for always sharing great information!

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