Mantle Cell Lymphoma Treatment Granted Breakthrough Therapy Designation

BeiGene’s investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib (BGB-3111), has been granted Breakthrough Therapy designation by the FDA for the treatment of adults with mantle cell lymphoma (MCL) who have received at least 1 prior therapy.

BeiGene’s investigational Bruton’s tyrosine kinase (BTK) inhibitor, zanubrutinib (BGB-3111), has been granted Breakthrough Therapy designation by the FDA for the treatment of adults with mantle cell lymphoma (MCL) who have received at least 1 prior therapy, according to a company press release.1

MCL is an aggressive form of non-Hodgkin lymphoma (NHL) that arises from B-cells originating in the “mantle zone,” according to BeiGene. Approximately 70,800 new cases of NHL were estimated in the United States in 2014, with MCL accounting for approximately 6%.1

The designation is based on data presented at the 60th Annual Meeting of the American Society of Hematology, which took place December 1-4, 2018. Results from the phase 2 trial of zanubrutinib in Chinese patients with relapsed or refractory MCL demonstrated a high rate of complete responses characterized by positron emission tomography-based imaging. For the study, patients were treated with zanubrutinib, dosed at 160 mg orally twice-daily.

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