AstraZeneca Pharma India gets CDSCO nod for expanded use of Calquence in Mantle Cell Lymphoma Treatment

Kinjal — Thu, 21 May 2026 07:59:56 +0000

AstraZeneca Pharma India has secured permission from the Central Drugs Standard Control Organization to import and market Acalabrutinib maleate tablets 100 mg, branded as Calquence, for an additional medical indication. The approval, granted on 20 May 2026, allows the use of Acalabrutinib in combination with Bendamustine and Rituximab (BR) for treating adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).

This regulatory nod marks a significant step for AstraZeneca Pharma India, enabling the company to market Calquence for this specific additional indication in India, pending any further necessary statutory approvals. The combination therapy is aimed at providing a new treatment option for MCL patients, potentially improving outcomes for those who have limited alternatives due to their ineligibility for stem cell transplants.

The approval reflects the ongoing efforts by AstraZeneca to expand the therapeutic applications of its products within India, aligning with the company’s strategy to address unmet medical needs in oncology. The introduction of Calquence for this new indication could offer a significant advancement in the management of mantle cell lymphoma, a challenging type of non-Hodgkin lymphoma.

Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).

mantle cell lymphoma | Business Upturn

AstraZeneca Pharma India gets CDSCO nod for expanded use of Calquence in Mantle Cell Lymphoma Treatment