China-based biotech BeiGene Inc. (HKG: 6160, SHA: 688235, NASDAQ: BGNE) announced receiving multiple marketing approvals in Latin America for its Bruton’s tyrosine kinase (BTK) inhibitor Brukinsa (zanubrutinib). The in-house developed drug is now approved for various indications across several Latin American countries.
Approvals and Indications
Brukinsa has received approval to treat relapsed/refractory (r/r) mantle cell lymphoma (MCL) in Argentina, Mexico, and Paraguay. It is also approved for r/r marginal zone lymphoma (MZL) and Waldenström’s macroglobulinemia (WM) in Chile, r/r MZL and WM in Ecuador, and r/r MCL, r/r MZL, and WM in El Salvador. These approvals expand the drug’s availability to patients in need across the region.
Global Regulatory Milestones
Supported by a broad clinical program that includes more than 4,500 subjects in 35 trials across 28 markets, Brukinsa has received approvals in over 55 countries and regions. These include major markets such as the United States, China, the EU, Switzerland, Great Britain, Canada, Australia, and other international markets.
Future Outlook
With these new approvals in Latin America, BeiGene continues to expand the global reach of Brukinsa, providing additional treatment options for patients with relapsed or refractory lymphomas and related conditions.-Fineline Info & Tech
