BeiGene’s Brukinsa Receives EC Approval for CLL Treatment

China-based biotech BeiGene Ltd. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) has announced receiving marketing approval from the European Committee (EC) for a new indication of its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The drug is now approved across the region to treat adult patients with treatment-naïve (TN) or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).

Approval Basis
The approval is based on the positive results of the Phase III SEQUOIA study in TN CLL and the Phase III ALPINE study in R/R CLL. Both studies demonstrated that Brukinsa is superior to bendamustine combined with rituximab as a first-line treatment for CLL and superior to ibrutinib in R/R CLL. The Independent Review Committee confirmed that Brukinsa has a higher overall response rate (80.4% vs 72.9%) compared to ibrutinib. Additionally, more patients receiving Brukinsa remain in remission after one year (90% vs 78%). The overall safety profile of Brukinsa is consistent with previous reports.

Global Development
Brukinsa was developed in-house by BeiGene and is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. The drug has obtained market approvals in the US, China, European Union, the UK, Canada, Australia, South Korea, and Switzerland, among a total of 58 markets. The latest approval in Europe follows the November 2021 approval for the drug as a second-line therapy for Waldenström’s macroglobulinaemia and as a first- or second-line therapy for marginal zone lymphoma (MZL), awarded earlier this month.

Future Implications
The EC approval for Brukinsa in CLL further solidifies BeiGene’s position in the global oncology market. This approval underscores the drug’s efficacy and safety, positioning it as a valuable treatment option for patients with CLL across Europe.-Fineline Info & Tech

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