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FDA grants priority review to zanubrutinib for relapsed/refractory mantle cell lymphoma
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The FDA granted priority review to zanubrutinib for the treatment of patients with relapsed or refractory mantle cell lymphoma, the drug’s manufacturer announced in a press release.
Zanubrutinib (BGB-3111, BeiGene), an investigational Bruton tyrosine kinase (BTK) inhibitor, received FDA breakthrough therapy designation in this setting earlier this year. It currently is being assessed in a broad, global pivotal clinical program as monotherapy and in combination with other agents to treat several B-cell lymphomas.
“Zanubrutinib, a potent and selective BTK inhibitor designed to maximize BTK occupancy and minimize off-target effects, has shown promise as a potential treatment for a number of B-cell malignancies,” Jane Huang, MD, chief medical officer of hematology at BeiGene, said in the release.
The FDA granted priority review of the new drug application based, in part, on data from a global phase 1/phase 2 trial among patients with B-cell lymphomas and a multicenter phase 2 trial among patients with relapsed or refractory mantle cell lymphoma, in addition to safety data on 641 patients from five trials and nonclinical data.
“We are conducting a broad global clinical development program for zanubrutinib that currently consists of eight phase 3 or potentially registration-enabling trials, including two head-to-head comparative trials, with approximately 1,500 patients treated across all programs,” Huang said.
The clinical trial program includes the fully enrolled, phase 3 ASPEN trial comparing zanubrutinib with ibrutinib (Imbruvica; Pharmacyclics, Janssen) among patients with Waldenström macroglobulinemia; the fully enrolled, phase 3 SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab (Rituxan; Genentech, Biogen) among patients with treatment-naive chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL); a pivotal phase 2 trial of zanubrutinib plus obinutuzumab (Gazvya, Genentech) among patients with relapsed or refractory follicular lymphoma; the phase 3 ALPINE trial comparing zanubrutinib with ibrutinib among patients with relapsed or refractory CLL or SLL; a phase 3 trial evaluating zanubrutinib among patients with treatment-naive mantle cell lymphoma; the pivotal phase 2 MAGNOLIA trial among patients with relapsed or refractory marginal zone lymphoma; and a phase 1 trial.
The FDA set a target action date of Feb. 27, 2020.