Regulatory10 April 2026 at 11:51 am
Calquence® Gets CDSCO Nod for New CLL/SLL Indication
AI Summary
AstraZeneca Pharma India Limited announced on April 9, 2026, that it has received permission from the Central Drugs Standard Control Organisation (CDSCO) to import and distribute Acalabrutinib tablets 100 mg (Brand name: Calquence®) for an additional indication. This approval allows Calquence® to be marketed in India for the treatment of patients with previously untreated chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL), when used in combination with venetoclax with or without obinutuzumab. This regulatory clearance is a significant step towards expanding the availability of this treatment option in India, subject to any further statutory approvals.
Key Highlights
- AstraZeneca India secured CDSCO approval for Calquence®.
- Approval is for an additional indication in untreated CLL/SLL.
- This expands the drug's market potential in India.
- Enhances treatment options for chronic lymphocytic leukaemia.