AstraZeneca Pharma India receives CDSCO approval for tumour-agnostic use of Trastuzumab Deruxtecan
New indication approved for treatment of unresectable or metastatic HER2-positive solid tumours in adult patients after prior systemic therapy
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 India.
Following this approval, Trastuzumab Deruxtecan is now indicated 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 is the first and only antibody drug conjugate (ADC) in India approved with a tumour-agnostic indication.
HER2 overexpression can occur across several solid tumour types, including breast, gastric, biliary tract, bladder, pancreatic, and gynaecological cancers. It is associated with aggressive disease, poor prognosis, and limited benefit from chemotherapy. While HER2-directed therapy has improved outcomes in some cancers, patients with other HER2-expressing tumours often progress on standard therapy and face poor outcomes.
Dr. Sandeep Arora, Director of Medical Affairs, AstraZeneca Pharma India, said, “This approval marks a pivotal milestone for patients living with advanced HER2-positive solid tumors in India. The decision draws on data from multicenter studies—including DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02—which evaluated Trastuzumab Deruxtecan in previously treated patients. These studies demonstrate the transformative impact of this therapy, opening new options for those who have exhausted conventional treatments. At AstraZeneca, our commitment is to drive precision oncology and deliver truly innovative solutions for patients and healthcare professionals.”
Trastuzumab Deruxtecan is already approved in India for the treatment of metastatic breast cancer (HER2-positive, HER2-low, and HER2-ultralow) and locally advanced or metastatic gastric cancer. The tumour-agnostic approval further expands its use to patients with other advanced HER2-positive cancers.
Praveen Rao Akkinepally, Country President & Managing Director, AstraZeneca Pharma India, said, “This milestone reflects our unwavering commitment to patient-centricity, scientific excellence, and equitable access to breakthrough therapies. By bringing Trastuzumab Deruxtecan to patients in India with HER2-positive solid tumors, we take a significant step forward in addressing unmet medical needs and transforming cancer care. Our ambition remains clear: to harness science and innovation to improve survival outcomes, redefine standards of care, and ultimately reduce the burden of cancer in India.”
The expanded indication is supported by results from three multicentre trials: DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. These studies evaluated 192 adult patients with previously treated unresectable or metastatic HER2-positive solid tumours. The confirmed objective response rates (ORR) were 51.4 per cent in DESTINY-PanTumor02, 52.9 per cent in DESTINY-Lung01, and 46.9 per cent in DESTINY-CRC02. Median progression-free survival (PFS) was recorded at 11.9 months, 6.7 months, and 5.8 months respectively.