Glenmark Pharmaceuticals Ltd. (Glenmark) a research-led, global pharmaceutical company, 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), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone
lymphoma (MZL), and follicular lymphoma (FL)1.
Globally, BRUKINSA is approved in more than 70 countries, supported by compelling clinical evidence from pivotal trials including ALPINE, ASPEN, and SEQUOIA.2 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.3,4 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.5
“We look forward to bringing BRUKINSA to India in the coming months as part of our ongoing partnership with
BeiGene (now BeOne Medicines),” said Alok Malik, President and Business Head – India Formulations,
Glenmark Pharmaceuticals Ltd. “This launch marks a significant milestone in our innovative oncology
portfolio, offering patients in India with access to a globally trusted therapy with proven efficacy and safety. It
underscores Glenmark’s ongoing commitment to providing effective and advanced treatments for patients with haemotological malignancies.
