Glenmark Pharmaceuticals has announced the upcoming India launch of BRUKINSA (zanubrutinib), following approval from the Drugs Controller General of India (DCGI). This milestone introduces India’s first and only BTK inhibitor approved for five B-cell malignancies, expanding treatment access for patients with hematological cancers.

Key highlights

DCGI approval for broad use

• BRUKINSA approved for five B-cell malignancies:

  1. Chronic Lymphocytic Leukemia (CLL)

  2. Small Lymphocytic Lymphoma (SLL)

  3. Waldenström Macroglobulinemia (WM)

  4. Mantle Cell Lymphoma (MCL)

  5. Marginal Zone and Follicular Lymphomas (MZL & FL)

Developed by BeOne medicines

• BRUKINSA is developed by BeiGene (now BeOne Medicines), an oncology innovator.

• Already approved in 70+ countries based on pivotal trials (ALPINE, ASPEN, SEQUOIA).

Glenmark’s oncology expansion

• Launch strengthens Glenmark’s innovative oncology pipeline in India.

• Collaboration with BeOne Medicines highlights global-local healthcare partnership.

Leadership speaks

• Alok Malik, President, Glenmark India Formulations: “This launch reaffirms our commitment to delivering global-standard cancer care to Indian patients.”

• Adam Roach, SVP, BeOne Medicines: “This marks an important milestone for expanding access to life-saving therapies in India.”

Glenmark’s launch of BRUKINSA is set to transform care for Indian patients with B-cell malignancies. As the first BTK inhibitor approved in India for multiple indications, it paves the way for more targeted, effective cancer therapies nationwide.