Glenmark Gets DCGI Nod to Launch Oncology Drug BRUKINSA in India

• Glenmark received DCGI approval to launch BRUKINSA in India

• The drug was developed by BeiGene, now known as BeOne Medicines

• Approved in over 70 countries, BRUKINSA is backed by strong clinical trials

Glenmark Pharmaceuticals has announced that it will shortly introduce zanubrutinib in India, soon after getting its recent approval from the Drugs Controller General of India (DCGI). BRUKINSA will be sold by a brand name in India, a groundbreaking first-in-class medicine invented by BeiGene, now rebranded as BeOne Medicines, a worldwide leader that is independent in oncology with a mission to drive front-line cancer medicines to patients globally. 

BRUKINSA is the first because it is the first and only Bruton's tyrosine kinase (BTK) inhibitor to have been approved in India for the treatment of five B-cell malignancies, i.e., chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), Waldenström macroglobulinemia (WM), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), and follicular lymphoma (FL).

Across the world, BRUKINSA has received approval in more than 70 nations and is backed by strong clinical evidence from key trials like ALPINE, ASPEN, and SEQUOIA. All of these trials prove the high efficacy, acceptable safety profile, and extensive therapeutic coverage of the drug.

Its introduction in India provides another option for treatment when the country still grapples with having a high incidence of severe and hard-to-treat hematologic malignancies. One individual in India develops blood cancer every five minutes, and almost 70,000 individuals die due to the disease annually. With its novel pharmacological profile, BRUKINSA solves an important unmet need, with high rates of response and sustained control of the disease across various B-cell cancers as demonstrated in pivotal clinical trials. Its dosing schedule, twice a day or once a day, also permits more individualized treatment.

In the ALPINE trial of relapsed/refractory chronic lymphocytic leukemia treatments, BRUKINSA also had a significantly reduced rate of serious cardiac adverse events (1.9 percent compared with 7.7 percent) and a significantly reduced discontinuation rate for cardiac adverse events (0.3 percent compared with 4.3 percent) compared with ibrutinib.

Also Read: Glenmark Announced Promising Results For Blood Cancer Drug

With BRUKINSA, Glenmark introduces in India a world-tested cancer therapy that assures superior clinical efficacy and better quality of life for patients suffering from difficult blood cancers.