Brukinsa BTK Inhibitor Treatment for Lymphoma
The United States Food and Drug Administration has granted accelerated approval to Brukinsa (zanubrutinib) for the treatment of patients with several kinds of lymphoma.
About Brukinsa
Brukinsa is a Bruton tyrosine kinase (BTK) inhibitor. Within lymphoma cells, BTK is a protein/carbohydrate complex that is involved in maintaining cellular survival and replication. By inhibiting the activity of BTK, a BTK inhibitor reduces the growth of lymphoma cells and causes cellular death. Drugs that block BTK stop the flow of these growth signals causing lymphoma cells to die.
Follicular Lymphoma
On March 7, 2024, the Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) in combination with Gazvya (obinutuzumab) for the treatment of relapsed or refractory follicular lymphoma based on the results in 217 adult patients with relapsed or refractory FL who had been treated with at least 2 prior systemic treatments.
The combination of Brukinsa and Gazvy produced and overall response to treatment in 69% of patients compared to 46% for those treated with Gazvya alone and the duration of the response was significantly longer.
Mantle Cell Lymphoma
The approval of Brukinsa for the treatment of recurrent MCL was based on a clinical trial evaluating the drug in 86 patients with MCL who had received at least 1 prior therapy. Patients received Brukinsa 160mg twice daily until their MCL progressed or they experienced unacceptable side effects. In the trial Burkinsa could be continued for up to 3 years.
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Overall 84% of the MCL patients enrolled in the trial demonstrated a response to treatment as evidenced by shrinkage of their MCL. A complete response or disappearance of the MCL occurred in 59% of patients and 24% of patients achieved a partial response. For individuals that responded to treatment the average duration of their response was 19.5 months.
“Mantle cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research. “For patients whose disease relapses or becomes refractory, secondary therapies may be successful in providing another remission, and today’s approval will provide patients with another treatment option.”
The most common side effects of Brukinsa are a decreased neutrophil count, decreased platelet count, upper respiratory tract infections, anemia, rash, bruising, diarrhea and cough.
The FDA previously granted Breakthrough Therapy and Orphan Drug designations to Brukinsa. The product will be available in the coming weeks in 80mg strength capsules.
Reference:
- https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-mantle-cell-lymphoma
- https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-zanubrutinib-relapsed-or-refractory-follicular-lymphoma
