Glenmark Pharmaceuticals isnow marketing in India a major development in the Indian oncology landscape by launching Brukinsa (zanubrutinib), an advanced therapy for certain blood cancers.
CDSCO records state that zanubrutinib 80 mg capsules were approved in India on April 8, 2025. Glenmark subsequently confirmed that BRUKINSA was launched in India during the first quarter of fiscal year 2025-26.
Brukinsa, a product developed by the global biotechnology firm BeOne Medicines, is a next-generation Bruton's tyrosine kinase (BTK) inhibitor. It is used in the treatment of diseases such as mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Glenmark will market the drug in India under a licensing agreement with BeiGene.
This approval comes at a time when demand for precision oncology treatments is growing. Brukinsa has already demonstrated a favorable safety profile and improved efficacy in international trials, including head-to-head comparisons with existing BTK inhibitors like ibrutinib. In one key study, patients on zanubrutinib showed higher progression-free survival rates with fewer adverse cardiovascular effects.
According to Glenmark, this launch is part of its broader strategy to expand its oncology portfolio and improve access to advanced cancer treatments across India. The company emphasized that Brukinsa offers not just therapeutic innovation but also a potentially improved quality of life for patients, due to its targeted mechanism and more favorable tolerability.
Glenmark subsequently reported that BRUKINSA and its other oncology launch, TEVIMBRA (tislelizumab), saw strong uptake in India following their Q1 FY2026 launches. The company continued to identify BRUKINSA as one of its key oncology products in later earnings updates
Alok Malik, Glenmark’s President and Business Head for India Formulations, stated that the company is committed to addressing unmet medical needs in hematology. “The introduction of zanubrutinib in India reinforces our focus on delivering next-generation therapies that are backed by robust clinical data,” he noted.
Globally, Brukinsa is approved in over multiple markets worldwide, including the United States, European Union, Canada, and China. Its arrival in India expanded the availability of zanubrutinib to another major market.
As India continues to see a rising burden of hematologic cancers, access to drugs like zanubrutinib could make a meaningful difference.
With the launch of Brukinsa, Glenmark strengthens its position as a key player in India’s growing oncology sector while offering another targeted treatment option for patients with eligible B-cell malignancies.
On June 9, 2026, Glenmark submitted bioequivalence data and requested permission to import and market its 160 mg tablet formulation of zanubrutinib for indications already approved in India.
An 80 mg capsule of zanubrutinib has already been approved in India, and the daily dose is 320 mg. A 160 mg tablet would allow the same daily dose to be given with fewer doses.
Based on the submitted bioequivalence data, the committee recommended permission for import and marketing of the 160 mg tablets and recommended a clinical-trial waiver.
DCGI marketing approval should not be considered final unless a subsequent CDSCO document confirms the decision.
Glenmark is also conducting post-marketing clinical evaluation of zanubrutinib in India.
In February 2026, the CDSCO Subject Expert Committee reviewed Glenmark's revised Phase IV clinical-trial protocol for zanubrutinib 80 mg capsules and recommended permission to conduct the study according to the revised protocol. The committee also stated that the final study report should be submitted to CDSCO for further review.
Reference:
1. Glenmark Pharmaceuticals. Glenmark to Launch DCGI-Approved BRUKINSA® in India to Advance Treatment of Hematological Malignancies. Glenmark Pharmaceuticals, May 2024. https://glenmark.b-cdn.net/gpl_pdfs/media/Glenmark_to_Launch_DCGI_approved_BRUKINSA%C2%AEin_India_to_Advance_Treatment_of_Hematological_Malignancies.pdf
2. Central Drugs Standard Control Organization (CDSCO). “Recommendations of the Subject Expert Committee (Oncology) Meeting Held on 09.06.2026.” June 9, 2026. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Oncology%2009.06.2026.pdf
3. Central Drugs Standard Control Organization (CDSCO). “Recommendations of the Subject Expert Committee (Oncology) Meeting Held on 11.02.2026.” February 11, 2026. https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2018/UploadCommitteeFiles/Recommendations%20Oncology%2011.02.2026.pdf
(Input from various sources)
(Rehash/M Subha Maheswari)