US FDA Approved BeiGene’s BRUKINSA to Treat Chronic Lymphocytic Leukemia


The global biotechnology company BeiGene announced that the Bruton’s tyrosine kinase inhibitor (BTKi) BRUKINSA (zanubrutinib) for the treatment of adult patients with CLL or SLL has received approval from the U.S. Food and Drug Administration (FDA).

Mehrdad Mobasher, Chief Medical Officer, Hematology at BeiGene, said that they believe BRUKINSA is well-positioned to become the BTKi of choice across multiple indications. With four US approvals in just over three years and demonstrated superiority versus ibrutinib in the final progression-free survival (PFS) analysis of the ALPINE trial, they believe BRUKINSA is well-positioned to become the BTK

Additionally, Mehrdad Mobasher said that they are thankful to the patients who participated in the ALPINE and SEQUOIA studies, and with this new approval, they will be excited to expand their impact to even more patients.

According to Jennifer R. Brown, director of the CLL Center of the Division of Hematologic Malignancies at Dana-Farber Cancer Institute, striking data from the BRUKINSA development program have demonstrated significant and consistent efficacy across all subtypes of CLL patients, including the high-risk mutated population, and regardless of treatment setting.

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Brian Koffman, Chief Medical Officer and Executive Vice-President of the CLL Society,said that tolerability is an important consideration because people with CLL can remain on therapy for years thanks to research that has produced innovative and effective medicines.

Brian Koffman is pleased that the approval of zanubrutinib provides a new BTKi option for people with CLL/SLL, and this option has demonstrated efficacy and is very well tolerated over the long term.