Zanubrutinib (Brukinsa) Receives FDA Approval for Follicular Lymphoma Treatment

If you have been diagnosed with follicular lymphoma (FL) that has returned after treatment (relapsed) or hasn't responded well to initial therapy (refractory), recent developments offer promising news. On March 7th, 2024, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib (Brukinsa, BeiGene, Ltd.) for treating adult patients with relapsed or refractory follicular lymphoma. Zanubrutinib is the first BTK inhibitor therapy approved in the US for this type of lymphoma.

What is Zanubrutinib?

Zanubrutinib belongs to a class of drugs called BTK inhibitors. These medications target a specific protein (Bruton's tyrosine kinase) involved in the growth and survival of specific cancer cells. By blocking BTK, zanubrutinib disrupts this process and may help control the growth of lymphoma cells.

How was Zanubrutinib Approved for Follicular Lymphoma?

The FDA's accelerated approval of zanubrutinib for follicular lymphoma was based on the results of a clinical trial, ROSEWOOD, involving adult patients with relapsed or refractory follicular lymphoma. The trial showed that zanubrutinib, combined with another medication called obinutuzumab (Gazyva, Genentech), achieved a higher overall response rate (ORR) compared to obinutuzumab alone. ORR refers to the percentage of patients whose cancer shrinks or disappears in response to treatment. It was reported that 69% of patients responded to this combination, and after 18 months of treatment, they were still in remission. 

Important Note: Accelerated FDA approval signifies that a drug shows promise based on early data, but further studies are required to confirm long-term benefits and safety. This is a favored practice in life-threatening diseases to ensure patients can access these therapies earlier.

What are the Potential Benefits and Risks of Zanubrutinib?

Based on the clinical trial, zanubrutinib combined with obinutuzumab may offer several potential benefits for patients with relapsed or refractory follicular lymphoma:
A New Mode to Target Lymphoma Cells: Zanubrutinib is the first drug of its type to be approved for patients with advanced follicular lymphoma who have already tried other approved therapies.
Improved Response Rates: The study suggests zanubrutinib, combined with obinutuzumab, may lead to a higher response rate than the current treatment, which was obinutuzumab alone.

Most patients who participated in the clinical trial experienced some type of side effect; however, more patients treated with the double therapy had more severe events than those receiving only one agent. The most frequent serious side effects reported with zanubrutinib combined with obinutuzumab were: 

• Altered blood work (low count of platelets and some types of white blood cells that fight infection)
• Pneumonia
• Diarrhea

Read more about the ROSEWOOD study and zanubrutinib’s results in follicular lymphoma here.

Who may be eligible for Zanubrutinib?

Zanubrutinib is currently approved in combination with obinutuzumab for adults with relapsed or refractory follicular lymphoma who have already undergone two or more previous therapies.

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