FDA Extends PDUFA Date for sNDA of Brukinsa


The FDA needs time to review additional clinical data submitted by BeiGene for the leukemia/lymphoma indication. The new date is Jan. 20, 2023.

The FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date by three months to Jan. 20, 2023 for the supplementary new drug application (sNDA) for BeiGene’s Brukinsa (zanubrutinib). The FDA is reviewing the therapy as a treatment for adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

The FDA extended the PDUFA date to allow time to review additional clinical data submitted by BeiGene. This includes the final response analysis from the global ALPINE clinical trial. The trial enrolled a total of 652 patients who received either Brukinsa or Imbruvica (ibrutinib) until disease progression or unacceptable toxicity. Imbruvica is jointly developed by Janssen and Pharmacyclics, an AbbVie company.

In April 2022, BeiGene announced results of the study, which showed that patients taking Brukinsa achieved a response rate of 80.4% versus 72.9% for Imbruvica. Safety analysis showed the rate of atrial fibrillation (rapid heart rate) or flutter continued to be lower in the Brukinsa arm. The rate of atrial fibrillation or flutter at 24.2 months of median follow-up was 4.6% in the Brukinsa arm and 12.0% in the Imbruvica arm.

In the Brukinsa arm, 13.0% of patients discontinued treatment due to adverse events compared with 17.6% of patients in the Imbruvica arm. The most commonly reported grade 3 or higher adverse events for Brukinsa were neutropenia (low white blood cell count), hypertension, pneumonia, neutrophil count decreased, and COVID-19 pneumonia.

The sNDA filing in chronic lymphocytic leukemia or small lymphocytic lymphoma includes data from two phase 3 studies and eight supportive studies in B-cell malignancies. The two global phase 3 trials are SEQUOIA comparing Brukinsa with bendamustine and rituximab in treatment-naïve patients and ALPINE comparing BRUKINSA with Imbruvica in relapsed or refractory patients. Additionally, the SEQUOIA study enrolled patients with deletion 17p in a non-randomized arm evaluating Brukinsa monotherapy in this high-risk population.

Brukinsa is approved for three indications in the United States: for the treatment of mantle cell lymphoma in adult patients who have received at least one prior therapy (November 2019); for the treatment of adult patients with Waldenström’s macroglobulinemia (August 2021); and for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen (September 2021)

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