BRUKINSA is now the only new-generation BTK inhibitor in China to have been approved for the first-line treatment of adults with CLL/SLL and Waldenström's macroglobulinemia
BeiGene secures new approvals for BRUKINSA in China. (Credit: Business Wire/BeiGene)
BeiGene’s Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA (zanubrutinib) has secured approvals from the China National Medical Products Administration (NMPA) for four applications.
The approvals include two supplemental new drug applications for treatment-naïve adults having chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) and Waldenström’s macroglobulinemia (WM).
Two supplemental applications of BeiGene have also been cleared by the NMPA, which are for conversions from conditional approval to regular approval. One of them is for the treatment of adults with CLL/SLL and mantle cell lymphoma (MCL) who had been subjected to at least one prior therapy.
The other approval is for the treatment of adults with Waldenström’s macroglobulinemia who had been given at least one prior therapy.
BRUKINSA is now the only approved new-generation BTK inhibitor in China for the first-line treatment of CLL/SLL and Waldenström’s macroglobulinemia in adults.
BeiGene R&D global head Lai Wang said: “These approvals further support BRUKINSA as the BTKi of choice in China for the treatment of B-cell malignancies such as CLL and WM.
“We look forward to bringing people living with CLL and WM a new first-line treatment option as we work to support the Healthy China initiative and reduce global health inequity.”
BRUKINSA’s new approvals for CLL/SLL are backed by the findings from the SEQUOIA phase 3 trial that featured patients with previously untreated CLL/SLL. It compared zanubrutinib to bendamustine plus rituximab (B+R).
The BTKi’s new approvals for Waldenström’s macroglobulinemia were driven by the results of the ASPEN phase 3 clinical trial. The late-stage trial compared zanubrutinib with ibrutinib.
The small molecule inhibitor of BTK is presently being studied globally in a broad clinical programme as both a monotherapy and in combination with other therapies for the treatment of multiple B-cell malignancies.
Earlier this year, BRUKINSA secured approval from the US Food and Drug Administration (FDA) for the treatment of adult patients with CLL/SLL.