FDA Clears New Option for Mantle Cell Lymphoma

Megan Brooks

November 14, 2019

The US Food and Drug Administration (FDA) has granted an accelerated approval to zanubrutinib (Brukinsa, BeiGene USA Inc) capsules for the treatment of adults with mantle cell lymphoma who have received at least one prior therapy.

"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, said in a news release.

"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," Pazdur said.

Mantle cell lymphoma is a fast-growing type of non-Hodgkin's lymphoma representing up to 10% of all non-Hodgkin's lymphomas in the US.

Zanubrutinib was tested in a single-arm clinical trial of 86 patients with mantle cell lymphoma who had received at least one prior treatment. In the trial, 84% of patients had tumor shrinkage with a median duration of response of 19.5 months.

Similar results were achieved in a second, single-arm trial of zanubrutinib that included 32 patients, in which 84% of patients had tumor shrinkage with a median duration of response of 18.5 months.

Common side effects seen in clinical testing including decreased neutrophil and platelet count, upper respiratory tract infection, decreased white blood cell count, decreased hemoglobin, rash, bruising, diarrhea, and cough.

During treatment, clinicians should monitor patients for hemorrhage, infection, cytopenias, and cardiac arrhythmias, the FDA said. Patients should use sun protection when taking zanubrutinib because there is a risk of other malignancies, including skin cancers.

Women who are pregnant or breast-feeding should avoid taking zanubrutinib as it may harm a developing fetus or newborn baby. Clinicians should advise women of reproductive age and males with a female partner of reproductive age to use effective contraception during treatment with the drug.

Zanubrutinib had breakthrough therapy designation, was an orphan drug, and received accelerated approval, a pathway used by the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients.

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