BeiGene receives FDA OK for Brukinsa

BeiGene has obtained the Food and Drug Administration’s green light for Bruton’s tyrosine kinase inhibitor Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma.

“With four U.S. approvals in just over three years and demonstrated superiority versus ibrutinib in the final progression-free survival analysis of the Alpine trial, we believe Brukinsa is well-positioned to become the BTKi of choice across multiple indications,” said Mehrdad Mobasher, chief medical officer, hematology at BeiGene. “We’re grateful to the patients who participated in the Alpine and Sequoia studies; and with this new approval, we’re excited to expand our impact to even more patients.”

[Read more: FDA approves Pfizer’s leukemia drug Besponsa]

“We have seen striking data from the Brukinsa development program demonstrating significant and consistent efficacy across CLL patient sub-types, including the high-risk del17p/TP53 mutated population, and regardless of treatment setting,” said Jennifer Brown, director of the CLL Center of the division of Hematologic Malignancies at Dana-Farber Cancer Institute. “With extensive follow-up across the CLL development program and the combined results from the Sequoia and Alpine trials, Brukinsa is established as a new standard of care for CLL.”

“Thanks to research that has delivered innovative and effective medicines, people with CLL can remain on therapy for years so tolerability is an important consideration. I’m pleased that the approval of zanubrutinib provides a new BTKi option for people with CLL/SLL, with demonstrated efficacy as well as being very well tolerated long-term,” said Brian Koffman, chief medical officer and executive vice-president at the CLL Society.