Fourth US approval for in-form Brukinsa

Chinese biotech company BeiGene (Nasdaq: BGNE) has announced that the US Food and Drug Administration (FDA) has approved Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

This latest approval in the USA, based on the results of the Phase III SEQUOIA and ALPINE trials, follows recent authorizations for the Bruton’s tyrosine kinase inhibitor in the UK and Europe.

Mehrdad Mobasher, chief medical officer, Hematology at BeiGene, said: “With four US 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.”