AstraZeneca Secures CDSCO Approval for Breast Cancer Drug Datopotamab Deruxtecan

AstraZeneca Pharma has received regulatory approval from India’s Central Drugs Standard Control Organisation (CDSCO) to import, sell and distribute Datopotamab Deruxtecan for the treatment of breast cancer. The approval marks AstraZeneca’s second antibody-drug conjugate (ADC) clearance in India, following trastuzumab deruxtecan.

Expanding Options for Advanced Breast Cancer Patients
Datopotamab Deruxtecan is indicated for patients with HR-positive, HER2-negative metastatic breast cancer and may be used earlier in the treatment pathway. AstraZeneca said the approval reflects its commitment to accelerating access to life-changing therapies for patients with high unmet medical needs in oncology.

Strengthening AstraZeneca’s Oncology Portfolio in India
Breast cancer remains the most commonly diagnosed cancer globally, with more than 2.3 million cases reported in 2022, and incidence in India has increased by nearly 40% over the past 25 years. The approval reinforces AstraZeneca’s strategy to expand its advanced oncology portfolio in India, particularly in antibody-drug conjugates, a rapidly growing class of targeted cancer therapies.