The CDSCO issued this approval on April 9, 2026, under the Directorate General of Health Services, Government of India.
With this approval, acalabrutinib tablets 100 mg, in conjunction with venetoclax and optionally obinutuzumab, are now indicated for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).
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The company stated that this permission allows for the import of Calquence tablets for sale and distribution in India for the specified additional indication. AstraZeneca Pharma India further noted that the marketing of acalabrutinib tablets 100 mg in the country for this new indication will depend on obtaining any necessary statutory approvals.
Last week, AstraZeneca Pharma India revealed it had secured approval from the CDSCO to import and market its cancer drug durvalumab (Imfinzi) for an additional indication in India.
In a filing with the exchange, the company stated that the approval permits the use of durvalumab solution for infusion (120 mg/2.4 mL and 500 mg/10 mL) for treating patients with unresectable hepatocellular carcinoma (uHCC) who have not undergone prior systemic therapy.
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Durvalumab is an immunotherapy used in cancer treatment, and the expanded indication focuses on liver cancer patients who cannot undergo surgical procedures.
AstraZeneca Pharma India Ltd shares closed at ₹8,291.50, gaining ₹235.70, or 2.93%, on the BSE today, April 10.
(Edited by : Shoma Bhattacharjee)
First Published: Apr 10, 2026 6:22 PM IST
