AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation to import its cancer drug Calquence 100 mg tablets for an additional therapeutic indication in India.
The regulatory nod allows the company to expand the use of Calquence, a targeted therapy used in the treatment of certain types of blood cancers, including chronic lymphocytic leukemia (CLL). The additional indication is expected to widen patient access to advanced treatment options in the country.
Calquence (acalabrutinib) belongs to a class of drugs known as Bruton’s tyrosine kinase (BTK) inhibitors, which work by blocking signals that help cancer cells grow and survive. The expanded approval reflects growing clinical evidence supporting its efficacy and safety in treating a broader set of conditions.
Industry experts note that the approval comes at a time when demand for targeted cancer therapies is increasing in India, driven by improved diagnostics and rising awareness. The move is likely to strengthen AstraZeneca’s oncology portfolio in one of its key growth markets.
The company is expected to work closely with healthcare providers and regulatory authorities to ensure timely availability of the drug following the import approval. Pricing and distribution strategies will play a crucial role in determining patient access.
The development underscores the continued focus of global pharmaceutical companies on expanding innovative treatment options in India, while aligning with the country’s regulatory framework to address unmet medical needs.