Glenmark Pharmaceuticals has announced the launch of zanubrutinib in India following approval by the Drugs Controller General of India (DCGI). The drug will be marketed under the brand name BRUKINSA®, developed by BeiGene (now BeOne Medicines), a global oncology company. This marks the introduction of the first Bruton’s tyrosine kinase (BTK) inhibitor in India approved for the treatment of five B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL).
BRUKINSA is approved in over 70 countries, backed by data from clinical studies such as ALPINE, ASPEN, and SEQUOIA. These trials have demonstrated consistent clinical outcomes across various B-cell cancers. The availability of BRUKINSA in India comes at a time when blood cancers continue to impact a large number of individuals. Estimates suggest that someone is diagnosed with blood cancer every five minutes in India, with annual deaths from the disease numbering around 70,000.
The treatment has shown high response rates and the ability to maintain disease control in patients with different types of B-cell malignancies. It also offers dosing flexibility, allowing for once or twice-daily administration. In the ALPINE study, BRUKINSA was compared with ibrutinib in relapsed or refractory CLL and showed a lower rate of serious cardiac events and fewer treatment discontinuations due to cardiac-related issues.
With its recent regulatory approval, BRUKINSA will now be available to patients in India who are affected by challenging hematological cancers.
