China-based BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the US FDA has approved its Bruton’s tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib) for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). In a separate announcement, BeiGene also noted that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted marketing authorizations for the drug for the treatment of CLL and marginal zone lymphoma (MZL) in adults who have received at least one prior anti-CD20-based therapy.
US Approval and Clinical Trial Data
The FDA approval is based on two global Phase III clinical trials demonstrating superior efficacy and a favorable safety profile for Brukinsa in CLL. The ALPINE trial (NCT03734016) compared Brukinsa against ibrutinib in previously treated patients with relapsed or refractory CLL or SLL. The SEQUOIA trial (NCT03336333) evaluated the efficacy and safety of Brukinsa compared to bendamustine + rituximab (B+R) in treatment-naïve CLL or SLL patients. These trials underscore Brukinsa’s potential as a next-generation BTK inhibitor.
UK Approval for Marginal Zone Lymphoma
The MHRA authorization for MZL is based on results from the MAGNOLIA trial (NCT03883184), a multicenter, global, single-arm, open-label Phase II study in patients with relapsed/refractory (R/R) MZL who received at least one anti-CD20-based regimen. This approval expands Brukinsa’s indications in the UK market.
Prior Approvals and FDA Review
Brukinsa is already approved in the US for several indications, including Waldenstrom’s macroglobulinemia (WM), mantle-cell lymphoma (MCL), and MZL. Prior to this approval, the FDA had delayed the PDUFA date to fully review additional data provided, including the remission evaluation results from the ALPINE study.-Fineline Info & Tech
