FDA Grants Priority Review to Zanubrutinib for Relapsed/Refractory Mantle Cell Lymphoma


Zanubrutinib, a Bruton’s tyrosine kinase inhibitor, is being evaluated in a broad pivotal clinical program across multiple B-cell malignancies.

Officials with the FDA have granted Priority Review for BeiGene’s New Drug Application (NDA) seeking approval for zanubrutinib for the treatment of patients with mantle cell lymphoma (MCL) who have received at least 1 prior therapy, according to a press release.

The agency previously granted Breakthrough Therapy designation for zanubrutinib earlier this year.

The NDA submission is based on data from a phase 1/2 trial in patients with B-cell lymphoma and an aggregate of 123 patients in the phase 2 trial of zanubrutinib in patients with relapsed or refractory MCL, as well as safety data on 641 patients from 5 clinical trials and non-clinical data.

MCL, which develops from B-cells originating in the “mantle zone,” is typically an aggressive form of non-Hodgkin lymphoma (NHL). Patients diagnosed with MCL typically have a median survival of 3 to 4 years, although patients may have an indolent course. MCL represents approximately 6% of all new cases of NHL, according to BeiGene.

Zanubrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, is being evaluated in a broad pivotal clinical program across multiple B-cell malignancies.

Current clinical trials involving zanubrutinib include:

  • The phase 3 ASPEN study in patients with Waldenström macroglobulinemia comparing zanubrutinib with ibrutinib.
  • The phase 3 SEQUOIA trial comparing zanubrutinib with bendamustine plus rituximab in patients with treatment-naive chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
  • A phase 2 trial in patients with relapsed/refractory follicular lymphoma in combination with obinutuzumab (Gazyva).
  • The phase 3 ALPINE trial comparing zanubrutinib to ibrutinib in patients with relapsed/refractory CLL/SLL.
  • The phase 3 trial in patients with untreated MCL.
  • The phase 3 MAGNOLIA trial in patients with relapsed/refractory marginal zone lymphoma.

“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 a statement. “We are proud to have submitted for first NDA in the US, which has now been accepted and designated Priority Review by the FDA for the treatment of patients with relapsed/refractory mantle cell lymphoma, an aggressive form of lymphoma. We are conducting a broad global clinical development program for zanubrutinib that currently consists of 8 phase 3 or potentially registration-enabling trial, including 2 head-to-head comparative trials, with approximately 1500 patients treated across all programs.”

The FDA has set a Prescription Drug User Fee Act target action date of February 27, 2020, according to BeiGene.


BeiGene Announces US FDA Acceptance and Grant of Priority Review for its New Drug Application of Zanubrutinib in Patients with Relapsed/Refractory Mantle Cell Lymphoma [news release]. BeiGene. http://ir.beigene.com/news-releases/news-release-details/beigene-announces-us-fda-acceptance-and-grant-priority-review. Accessed August 22, 2019.

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