Glenmark receives DCGI approval to launch oncology drug BRUKINSA in India

Business Standard

5 hours ago

Glenmark Pharmaceuticals has announced the upcoming launch of zanubrutinib in India following approval by the Drugs Controller General of India (DCGI).
Zanubrutinib will be marketed in India under the brand name BRUKINSA, an innovative therapy developed by BeiGene (now BeOne Medicines), a global oncology leader committed to delivering advanced treatments for cancer patients worldwide. BRUKINSA is the first and only Bruton's tyrosine kinase (BTK) inhibitor approved in India for the treatment of five distinct B-cell malignancies: chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenstr macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL).
Globally, BRUKINSA is approved in more than 70 countries, supported by compelling clinical evidence from pivotal trials including ALPINE, ASPEN, and SEQUOIA. This extensive clinical program underscores BRUKINSA's proven efficacy, strong safety profile, and broad therapeutic value.
The introduction of BRUKINSA brings an innovative treatment option at a time when India continues to face a significant burden from serious and difficult-to-treat haematological malignancies. According to various sources, someone in India is diagnosed with blood cancer every five minutes, and an estimated 70,000 people die from the disease each year. BRUKINSA addresses a critical unmet need with its differentiated pharmacological profile, demonstrating high response rates and durable disease control across multiple B-cell malignancies as shown in pivotal clinical trials. BRUKINSA's flexible dosing regimen (once or twice daily) supports personalized care.1 In the head-to-head ALPINE study in relapsed/refractory chronic lymphocytic leukemia, BRUKINSA demonstrated a lower rate of serious cardiac events (1.9% vs. 7.7%) and fewer treatment discontinuations due to cardiac issues (0.3% vs. 4.3%) compared with ibrutinib.