AstraZeneca Pharma India has received regulatory approval to import and market Acalabrutinib tablets 100 mg, branded as Calquence®, for an additional medical indication. The Central Drugs Standard Control Organisation, under the Directorate General of Health Services, Government of India, granted this permission on 9 April 2026.
The approval allows the use of Acalabrutinib tablets 100 mg in combination with venetoclax, with or without obinutuzumab, for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). This development marks a significant step for AstraZeneca Pharma India as it expands the therapeutic use of Calquence® in the Indian market.
The company has stated that the receipt of this permission facilitates the marketing of Calquence® in India for the specified additional indication. However, this is contingent upon obtaining any other necessary statutory approvals.
Disclaimer: This article is based on a regulatory filing submitted to the National Stock Exchange of India (NSE).