AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, sell and distribute its breast cancer therapy Datopotamab Deruxtecan in India.

The approval enables the introduction of the antibody-drug conjugate in the Indian market and marks AstraZeneca’s second such therapy to receive regulatory clearance in the country. The company said the nod reflects its continued focus on bringing innovative oncology treatments to Indian patients.

Datopotamab Deruxtecan is indicated for the treatment of patients with hormone receptor-positive, HER2-negative metastatic breast cancer and offers a new targeted treatment option that may be used earlier in the disease setting.

Breast cancer is the most commonly diagnosed cancer globally and continues to see a rising incidence in India, highlighting the need for timely access to advanced and effective therapies.