FDA Approves Zanubrutinib to Treat Mantle Cell Lymphoma

The FDA granted accelerated approval to zanubrutinib for the treatment of adult patients with MCL who have received at least 1 prior therapy.

The FDA granted accelerated approval to zanubrutinib (Brukinsa) capsules for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy, according to the agency.

The FDA based its approval on data from the single-arm clinical trial of zanubrutinib – designed to evaluate the agent in 86 patients with MCL. The trial aimed to evaluate overall response rate (ORR).

Eighty-four percent of patients experienced tumor shrinkage with a median duration of response of 19.5 months on the BTK inhibitor.

Common adverse events (AEs) included decreased neutrophil count, decreased platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, and cough.

This approval comes more than 3 months ahead of the agency’s PDUFA date.

"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."


The recommended dose of oral zanubrutinib is 320 mg, taken either 160 mg twice daily or 320 mg once daily, with or without food. The dose can be adjusted for adverse events (AEs), and can be reduced for patients with severe hepatic impairment and certain drug interactions, according to a statement issued by BeiGene, the developer of zanubrutinib.