Brukinsa Receives FDA Approval for Patients with Mantle-Cell Lymphoma

On November 14, 2019, the FDA granted accelerated approval to zanubrutinib (Brukinsa; BeiGene) for the treatment of patients with mantle-cell lymphoma who have received ≥1 previous therapies.

“Mantle-cell lymphoma usually responds well to initial treatment, but eventually returns or stops responding, and the cancer cells continue to grow. This is a life-threatening condition,” said Richard Pazdur, MD, Director of the FDA’s Oncology Center of Excellence. “Clinical trials showed that 84% of patients saw tumor shrinkage with this therapy. 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,” he said.

The efficacy of zanubrutinib was assessed in 2 clinical trials. In the phase 2, multicenter, single-arm BGB-3111-206 trial, 86 previously treated patients with relapsed or refractory mantle-cell lymphoma who had ≥1 previous therapies received 160 mg of zanubrutinib orally twice daily until disease progression or unacceptable toxicity. In the phase 1/2, dose-escalation, multicenter, single-arm BGB-3111-AU-003 trial of B-cell malignancies, 32 previously treated patients with mantle-cell lymphoma received 160 mg of zanubrutinib orally twice daily or 320 mg once daily.

The primary efficacy end point in both trials was overall response rate as assessed by an Independent Review Committee. In the BGB-3111-206 trial, the overall response rate was 84% (95% confidence interval [CI], 74-91), with a complete response rate of 59% (95% CI, 48-70) and a median response duration of 19.5 months (95% CI, 16.6-not estimable). In the BGB-3111-AU-003 trial, the overall response rate was 84% (95% CI, 67-95), with a complete response rate of 22% (95% CI, 9-40) and a median response duration of 18.5 months (95% CI, 12.6-not estimable).

The most common (≥20%) adverse reactions in patients treated with zanubrutinib included decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, and cough. Serious adverse reactions were reported in 31% of patients. The most frequent serious adverse reactions were pneumonia in 11% and hemorrhage in 5% of patients.

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