AstraZeneca receives DCGI nod for expanded use of Calquence cancer therapy

AstraZeneca Pharma India Ltd. on Thursday said it has received approval from the Central Drugs Standard Control Organization (CDSCO) for an additional indication for its cancer therapy Calquence (Acalabrutinib maleate tablets 100 mg).

In an exchange filing, the company said the approval was granted on May 20, 2026, by the Directorate General of Health Services, Government of India.

With the latest approval, Acalabrutinib in combination with Bendamustine and Rituximab (BR) can now be used for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are not eligible for autologous stem cell transplant (ASCT).

The approval paves the way for the marketing and distribution of Calquence in India for the newly approved indication, subject to other applicable statutory approvals.

Mantle cell lymphoma is a rare and aggressive form of non-Hodgkin lymphoma that affects B-cells, and the latest approval expands AstraZeneca’s oncology treatment portfolio in India.

AstraZeneca has been strengthening its oncology presence globally through targeted therapies across lung cancer, blood cancer and rare disease segments. Calquence is one of the company’s key haematology-focused therapies aimed at improving outcomes in blood cancer treatment.

The company informed exchanges that the disclosure was made under Regulation 30 of SEBI’s Listing Obligations and Disclosure Requirements (LODR) Regulations.

AstraZeneca Pharma India is engaged in the manufacture, distribution and marketing of pharmaceutical products and operates across multiple therapy areas including oncology, cardiovascular, respiratory and rare diseases.

Disclaimer: This article is for informational purposes only and should not be construed as investment advice.