AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, market, and distribute Trastuzumab Deruxtecan (100mg/5mL vial lyophilised powder for concentrate for solution for infusion) for an additional indication in the country.
With this regulatory clearance, Trastuzumab Deruxtecan 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 milestone makes it the first and only antibody-drug conjugate (ADC) in India with a tumour-agnostic indication, marking a major step forward in precision oncology.
HER2 overexpression is seen across multiple solid tumours—including breast, gastric, biliary tract, bladder, pancreatic, and gynecological cancers—and is linked to aggressive disease, poor prognosis, and limited benefit from conventional chemotherapy. While HER2-targeted therapies have improved outcomes in select cancers, many patients with other HER2-expressing tumours continue to progress on standard treatments and face poor survival outcomes.
In India, Trastuzumab Deruxtecan is already approved for metastatic breast cancer (HER2-positive, HER2-low, and HER2-ultralow) as well as for locally advanced or metastatic gastric cancer. The new tumour-agnostic indication expands its potential to provide meaningful benefit to patients across a broader spectrum of advanced HER2-positive cancers.