Zanubrutinib


Zanubrutinib, sold under the brand name Brukinsa, is for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.
It was approved for medical use in the United States in November 2019.
Zanubrutinib is classified as a Bruton's tyrosine kinase inhibitor. It is administered orally.

History

Efficacy was evaluated in BGB-3111-206, a phase II open-label, multicenter, single-arm trial of 86 patients with mantle cell lymphoma who received at least one prior therapy. Zanubrutinib was given orally at 160 mg twice daily until disease progression or unacceptable toxicity. Efficacy was also assessed in BGB-3111-AU-003, a phase I/II, open-label, dose-escalation, global, multicenter, single-arm trial of B‑cell malignancies, including 32 previously treated MCL patients treated with zanubrutinib administered orally at 160 mg twice daily or 320 mg once daily.
The primary efficacy outcome measure in both trials was overall response rate, as assessed by an independent review committee. In trial BGB-3111-206, FDG-PET scans were required and the ORR was 84%, with a complete response rate of 59% and a median response duration of 19.5 months. In trial BGB-3111-AU-003, FDG-PET scans were not required and the ORR was 84%, with a complete response rate of 22% and a median response duration of 18.5 months. Trial 1 was conducted at 13 sites in China, and Trial 2 was conducted at 25 sites in the United States, United Kingdom, Australia, New Zealand, Italy, and South Korea.
The U.S. Food and Drug Administration granted zanubrutinib priority review, accelerated approval, breakthrough therapy designation, and orphan drug designation.
The FDA approved zanubrutinib in November 2019, and granted the application for Brukinsa to BeiGene USA Inc.