AstraZeneca Pharma India Limited has received regulatory approval for an additional indication for Acalabrutinib (Calquence). The therapy is now approved for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL). The drug will be administered in combination with venetoclax, with or without obinutuzumab, marking a significant expansion in the company’s oncology treatment offerings in India.
Expanding Oncology Treatment Options
On April 9, 2026, AstraZeneca Pharma India Limited secured permission to import and distribute Acalabrutinib 100 mg tablets (marketed as Calquence) for a expanded clinical use. This approval allows the drug to be used for the treatment of previously untreated chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
Clinical Application
The newly approved treatment regimen involves the use of Acalabrutinib 100 mg in combination with venetoclax, both with or without the administration of obinutuzumab. This therapeutic approach provides a new option for patients battling these specific blood cancers, strengthening the company’s portfolio in the haematology segment.
Next Steps for Market Availability
With this regulatory milestone achieved, the company is set to begin the marketing of Calquence for this specific indication across India. The rollout remains subject to any remaining necessary statutory approvals, paving the way for improved access to this advanced oncology therapy for Indian patients.
Source: BSE
