The FDA has accepted a supplemental new drug application (sNDA) for the Bruton tyrosine kinase (BTK) inhibitor zanubrutinib (Brukinsa) for the treatment of adult patients with Waldenström macroglobulinemia (WM), according to the drug’s developer, BeiGene.1
A prescription drug user fee act (PDUFA) target action date has been set by the FDA for October 18, 2021.
The sNDA submission was primarily based on safety and efficacy data from the global phase 3 ASPEN trial (NCT03053440) of zanubrutinib compared with ibrutinib (Imbruvica) for the treatment of WM, with supportive data from a pivotal phase 2 trial (NCT03332173) of zanubrutinib in relapsed or refractory WM conducted in China and a global phase 1/2 trial (NCT02343120) in patients with B-cell malignancies. Overall, the culmination of these trials included data from 351 patients with WM.
Additionally, safety data from 779 patients…