FDA grants priority review to Brukinsa for pretreated marginal zone lymphoma
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The FDA granted priority review designation to zanubrutinib for treatment of certain adults with marginal zone lymphoma, according to the agent’s manufacturer.
The designation applies to use of the agent by patients who received at least one prior anti-CD20-based therapy.
Zanubrutinib (Brukinsa, BeiGene) — a Bruton tyrosine kinase inhibitor — is in development for use as monotherapy or in combination with other agents for treatment of various B-cell malignancies.
The agent is approved in the United States for treatment of adults with mantle cell lymphoma who received at least one prior therapy.
“This is our first regulatory submission in marginal zone lymphoma, a serious disease diagnosed in more than 2,000 patients every year in the U.S., with no clear standard of care,” Jane Huang, MD, BeiGene’s chief medical officer for hematology, said in a company-issued press release. “In clinical trials, Brukinsa has demonstrated promising efficacy and tolerability in marginal zone lymphoma and presents a potential new option for [this patient population].”
The FDA based the priority review in part on results of the phase 2 MAGNOLIA trial. Preliminary results of the multicenter, open-label, single-arm trial — presented at last year’s ASH Annual Meeting and Exposition — showed the agent is active among patients with relapsed or refractory marginal zone lymphoma. The agent also exhibited a favorable safety profile, according to researchers.
The FDA is expected to make a decision on this application by Sept. 19.
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