By: IPP Bureau
Last updated : June 11, 2026 7:30 pm
Approval expands treatment options for patients with unresectable or metastatic HER2-positive breast cancer
The Central Drugs Standard Control Organisation (CDSCO) has approved AstraZeneca Pharma India's additional indication for Trastuzumab Deruxtecan 100 mg/5 mL vial lyophilized powder for concentrate for solution for infusion, in combination with Pertuzumab, as a first-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer.
Despite advances in treatment, significant unmet needs remain for patients with metastatic HER2-positive breast cancer. Notably, nearly one-third of patients who receive first-line treatment do not proceed to second-line therapy, underscoring the importance of administering the most effective treatments as early as possible in the disease course.
The CDSCO approval is based on findings from the DESTINY-Breast09 clinical trial, which included patients from India. The study demonstrated that the combination of Trastuzumab Deruxtecan and Pertuzumab delivered a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with the current standard THP regimen comprising taxane, trastuzumab, and pertuzumab.
Patients treated with Trastuzumab Deruxtecan plus Pertuzumab achieved a median progression-free survival of 40.7 months, compared with 26.9 months for those receiving the THP regimen.
Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited, said, “This approval marks an important step forward for patients with unresectable or metastatic HER2-positive breast cancer in India, where the need for more effective treatment options in the first-line setting remains high.”
He added, “At AstraZeneca, our purpose is to transform patient outcomes through science, and we are committed to accelerating the introduction of important new medicines to India, helping patients access advances in care sooner while working with the broader healthcare ecosystem to reduce barriers and improve quality of life.”