China-based biotech company BeiGene Inc. (Nasdaq: BGNE) will experience a three-month delay in its pursuit of US approval for its Bruton’s tyrosine kinase (BTK) inhibitor, Brukinsa (zanubrutinib), for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL). The US Food and Drug Administration (FDA) has pushed back the Prescription Drug User Fee Act (PDUFA) goal date to January 20, 2023, to review new data submitted by BeiGene in support of its supplementary new drug application (sNDA).
New Data from ALPINE Study
The additional data comes from the global ALPINE study, which demonstrated Brukinsa’s superiority over ibrutinib with an overall response rate (ORR) of 80.4% versus 72.9% in adult patients with relapsed or refractory (R/R) CLL/SLL, as assessed by an Independent Review Committee (IRC). The study included 652 patients across sites in Europe and the US, among other locations, and is ongoing with plans to analyze other key secondary endpoints such as progression-free survival (PFS).
Current US Approvals and Future Outlook
Brukinsa is already approved in the US for smaller indications including Waldenstrom’s macroglobulinemia (WM), mantle-cell lymphoma (MCL), and marginal zone lymphoma (MZL). Industry watchers expect eventual approval for CLL/SLL, especially since the US National Comprehensive Cancer Network has endorsed Brukinsa as a treatment for CLL/SLL in its latest guidelines.
International Approvals
In a separate announcement, BeiGene revealed that Brukinsa has received market approvals to treat MCL in Kuwait, Bahrain, and Qatar, marking further progress for the drug in international markets.-Fineline Info & Tech
