BeiGene’s Brukinsa sNDA Decision Date Pushed Back to Next Year

The FDA has delayed its user fee decision date for BeiGene’s supplemental New Drug Application (sNDA) for Brukinsa (zanubrutinib) from Oct. 22, 2022, to Jan. 20, 2023.

If successful, the sNDA would expand Brukinsa’s approved indications to include adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma, two forms of non-Hodgkin lymphoma.

The agency said the extension was to allow time to review additional data from the company, which the agency considers a major amendment to the sNDA.

In August 2021, the FDA approved Brukinsa for treatment of patients with Waldenström’s macroglobulinemia and granted accelerated approval a month later for patients with mantle cell lymphoma and patients with relapsed or refractory marginal zone lymphoma.