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Dr. Tam on Zanubrutinib Approval in MCL
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Constantine S. Tam, MD, MBBS, discusses the FDA approval of zanubrutinib in mantle cell lymphoma.
Constantine S. Tam, MD, MBBS, associate professor, Peter MacCallum Cancer Centre, discusses the FDA approval of zanubrutinib (Brukinsa) in mantle cell lymphoma (MCL).
In November 2019, the FDA granted an accelerated approval to zanubrutinib capsules for the treatment of adult patients with MCL who have received ≥1 prior therapy, explains Tam.
The approval is based on 2 single-arm studies that showed high response rates with the BTK inhibitor. In the open-label, multicenter, phase II BGB-3111-206 trial (NCT03206970) conducted in China, the complete response rate was 59%, which was substantially higher than reports for ibrutinib, Tam concludes.
