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FDA Approves Zanubrutinib for Relapsed/Refractory MCL

Gina Columbus @ginacolumbusonc
Published: Friday, Nov 15, 2019

The FDA has granted an accelerated approval to zanubrutinib (Brukinsa) capsules for the treatment of adult patients with mantle cell lymphoma (MCL) who have received ≥1 prior therapy.1

The approval, which occurred more than 3 months ahead of the FDA's action date, is based on findings from two single-arm studies, in which zanubrutinib elicited an overall response rate (ORR) of 84% in patients with MCL who received ≥1 prior treatment.2

"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," 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, stated in a press release. "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."

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