AstraZeneca secures CDSCO approval for expanded use of Trastuzumab Deruxtecan in HER2-positive solid tumors

New Delhi: AstraZeneca Pharma India Limited has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import, market, and distribute Trastuzumab Deruxtecan (100mg/5mL vial lyophilized powder for concentrate for solution for infusion) for an additional indication in India.

With this approval, Trastuzumab Deruxtecan is now indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic therapy and have no satisfactory alternative treatment options. This marks the first and only antibody drug conjugate (ADC) in India with a tumour-agnostic indication, representing a significant advancement in precision oncology.

HER2 overexpression, which can occur across a range of solid tumors—including breast, gastric, biliary tract, bladder, pancreatic, and gynecological cancers—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 tumors often progress on standard therapy and face poor outcomes.

Commenting on the approval, Dr. Sandeep Arora, Director of Medical Affairs, AstraZeneca Pharma India Limited, 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 broadens its potential to benefit patients across a range of advanced HER2-positive cancers.

Praveen Rao Akkinepally, Country President & Managing Director, AstraZeneca Pharma India Limited, added, “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 approval is supported by results from three key multicenter trials — DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02 — which evaluated 192 adult patients with previously treated unresectable or metastatic HER2-positive solid tumors. Confirmed objective response rates (ORR) were 51.4% in DESTINY-PanTumor02, 52.9% in DESTINY-Lung01, and 46.9% in DESTINY-CRC02, with durable responses observed across tumor types. Median progression-free survival (PFS) reached 11.9 months, 6.7 months, and 5.8 months respectively, underscoring the clinical benefit across diverse patient populations.