FDA Accepts sNDA for Zanubrutinib in Waldenström Macroglobulinemia

The FDA has accepted a supplemental new drug application (sNDA) for zanubrutinib for the treatment of adults with Waldenström macroglobulinemia (WM).

The sNDA, submitted by zanubrutinib’s manufacturer BeiGene, includes data from the global phase III ASPEN trial, which compared zanubrutinib with ibrutinib in the treatment of patients with WM, in addition to supportive data from a phase II trial conducted in China and a global phase I/II trial enrolling patients with B-cell malignancies.

In June 2020, zanubrutinib was approved in China for the treatment of adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have received at least one prior therapy, as well as patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Earlier, in November 2019, zanubrutinib received accelerated approval in the U.S. for the treatment of MCL in adult patients who have undergone at least one prior therapy.

Zanubrutinib is also under regulatory review for the treatment of patients with WM in the E.U., Canada, Australia, China, Taiwan, and South Korea. The Prescription Drug User Fee Act target action date is October 18, 2021.

Sources: BeiGene press release, February 17, 2021; ClinicalTrials.gov NCT03053440; ClinicalTrials.gov NCT03332173; ClinicalTrials.gov NCT02343120.