Glenmark Pharmaceuticals Receives DCGI Approval to Launch BRUKINSA for Five B-Cell Malignancies in India
Key Insights
Glenmark Pharmaceuticals has received DCGI approval to launch zanubrutinib (BRUKINSA) in India, marking the first BTK (search) inhibitor approved for treating five distinct B-cell malignancies (search).
BRUKINSA is approved for chronic lymphocytic leukemia (search)/small lymphocytic lymphoma (search), Waldenström macroglobulinemia (search), mantle cell lymphoma (search), marginal zone lymphoma (search), and follicular lymphoma (search).
The drug is already approved in more than 70 countries globally and is supported by clinical evidence from pivotal trials including ALPINE, ASPEN, and SEQUOIA.
Mumbai-based Glenmark Pharmaceuticals has announced the upcoming 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, representing a significant milestone in expanding access to innovative oncology treatments for Indian patients with hematological malignancies.
First BTK Inhibitor Approved in India
BRUKINSA stands as the first and only Bruton's tyrosine kinase (search) (BTK (search)) inhibitor approved in India for treating five distinct B-cell malignancies (search): chronic lymphocytic leukemia (search)/small lymphocytic lymphoma (search) (CLL/SLL), Waldenström macroglobulinemia (search) (WM), mantle cell lymphoma (search) (MCL), marginal zone lymphoma (search) (MZL), and follicular lymphoma (search) (FL).
The innovative therapy was originally developed by BeiGene (search) (now BeOne Medicines (search)), a global oncology leader committed to delivering advanced treatments for cancer patients worldwide. The approval marks a crucial expansion of treatment options for patients with these challenging hematological conditions.
Global Clinical Evidence and Regulatory Success
BRUKINSA has demonstrated its therapeutic value through extensive global adoption, with approvals in more than 70 countries worldwide. The drug's regulatory success is 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 across multiple B-cell malignancies (search).
Strategic Partnership and Market Access
"We look forward to bringing BRUKINSA to India in the coming months as part of our ongoing partnership with BeiGene (search) (now BeOne Medicines (search))," 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 haematological malignancies."
Adam Roach, Senior Vice President and Head of Japan and Asia Pacific region for BeiGene (search) (to be renamed BeOne Medicines (search)), emphasized the regional significance of this development: "The introduction of BRUKINSA in India marks an important step in our ongoing mission to expand patient access to innovative oncology treatments across the Asia Pacific region."
The launch is expected to occur in the coming months, providing Indian oncologists and patients with access to this globally established BTK (search) inhibitor therapy for the treatment of multiple B-cell malignancies (search).