Added support for use of Brukinsa in relapsed or refractory CLL/SLL

An interesting study on a drug, Brukinsa that is not yet in New Zealand, although we and Australia had 9% of patients enrolled in the trial. Hopefully the drug will make it to New Zealand at some stage in the future.

“China-based biotech BeiGene (HKEX: 06160) has announced results from the Phase III ALPINE trial showing BTK inhibitor Brukinsa (zanubrutinib) demonstrated superiority versus ibrutinib in overall response rate (ORR) as assessed by an Independent Review Committee (IRC) in adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

A total of 652 patients were enrolled in the ALPINE trial across:

Europe (60%) ; USA (17%) ;  China (14%) ; New Zealand and Australia (9%) and were followed for a median of 24.2 months. The next planned analysis of ALPINE data will be the PFS final analysis.

Brukinsa, which is cleared in markets such as the European Union, USA, China, Brazil and Canada for the treatment of marginal zone lymphoma (MZL) and mantle cell lymphoma (MCL) in some markets.

BeiGene has submitted results from the ALPINE trial in support of marketing authorization applications for Brukinsa in CLL in the USA, EU and other markets around the world. In February 2022, BeiGene announced that the US Food and Drug Administration and European Medicines Agency have accepted supplemental new drug applications for Brukinsa in CLL”.

For more information on the trial, please click on this link: Added support for use of Brukinsa in relapsed or refractory CLL/SLL (thepharmaletter.com)