FDA Brief: Supplemental New Drug Application Accepted for Zanubrutinib in CLL

By: Lauren Velentzas
Posted: Monday, February 28, 2022

On February 22, the biotechnology company BeiGene announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental new drug application for zanubrutinib (Brukinsa) for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. Zanubrutinib is a small-molecule inhibitor of Bruton’s tyrosine kinase (BTK) that is currently being globally evaluated as a monotherapy and in combination with other therapies to treat various B-cell malignancies.

The new drug application filing is based on data from two randomized phase III studies—ALPINE (ClinicalTrials.gov identifier NCT03734016) and SEQUOIA (NCT03336333)—and eight supportive studies in B-cell malignancies. Zanubrutinib has previously been approved in the United States for treatment of mantle cell lymphoma in adults who have received at least one prior therapy, adults with Waldenström’s macroglobulinemia, and adults with relapsed or refractory marginal zone lymphoma who have received at least one anti–CD20-based regimen.

“While previously approved BTK inhibitors have been transformational for some patients with CLL, there continues to be [an] unmet need, as not all patients achieve a favorable clinical response, while others are unable to tolerate currently approved BTKi therapies,” said Jennifer R. Brown, MD, PhD, Director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, and a principal investigator of the two studies.

Businesswire

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