AstraZeneca Pharma India has obtained approval from the Central Drugs Standard Control Organisation (CDSCO) to import, market, and distribute Trastuzumab Deruxtecan (100mg/5mL vial lyophilised powder) for an expanded indication in the country.

With this clearance, the drug is now approved for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have received prior systemic therapy and have no satisfactory alternative treatment options. This makes Trastuzumab Deruxtecan the first and only ADC in India to receive a tumour-agnostic indication, marking a major milestone in advancing precision oncology.

HER2 overexpression—seen in various solid tumours such as breast, gastric, biliary tract, bladder, pancreatic, and gynaecological cancers—is often linked with aggressive disease progression, poor prognosis, and limited chemotherapy response. While HER2-targeted therapies have transformed outcomes in certain cancers, patients with other HER2-expressing tumours have had few effective treatment choices.

Trastuzumab Deruxtecan is already approved in India for HER2-positive, HER2-low, and HER2-ultra-low metastatic breast cancer, as well as locally advanced or metastatic gastric cancer. The new tumour-agnostic approval significantly expands its therapeutic potential, offering hope to a broader group of patients with advanced HER2-positive malignancies.