CDSCO Approves AstraZeneca's Enhertu as New First-Line Combination for HER2-Positive Breast Cancer in India
- Badari Andukuri
- 9 minutes ago
- 2 min read
AstraZeneca Pharma India has secured regulatory clearance from the Central Drugs Standard Control Organisation (CDSCO) to introduce a new first-line therapeutic option for adults facing unresectable or metastatic HER2-positive breast cancer. The approved regimen pairs trastuzumab deruxtecan with pertuzumab.
Given the aggressive nature of HER2-positive breast cancer, which stems from HER2 gene amplification and impacts a significant portion of Indian patients, this approval addresses a critical clinical need. Maximizing early-stage treatment efficacy remains vital in metastatic care, as many patients never advance to subsequent lines of therapy.
Clinical Data Supporting the Approval
The CDSCO's decision rests on efficacy data from the global DESTINY-Breast09 clinical trial, which featured active participation from Indian clinical sites.
The Comparison: The trial evaluated the novel trastuzumab deruxtecan and pertuzumab combination against the traditional standard-of-care THP regimen (a taxane combined with trastuzumab and pertuzumab).
Survival Outcomes: Investigators reported a median progression-free survival (PFS) of 40.7 months for patients on the trastuzumab deruxtecan combination, compared to 26.9 months for those receiving THP.
Risk Reduction: This represents a 44% reduction in the risk of disease progression or mortality.
Because these survival benefits persisted across all analyzed patient subgroups, oncology professionals now have a robust, evidence-based alternative to alter patient outcomes early in the metastatic treatment timeline.
Expanding Oncology Indications of Enhertu in India
This regulatory milestone further expands the clinical footprint of trastuzumab deruxtecan. Beyond this newly approved first-line setting, the therapeutic agent maintains indications for:
Previously treated HER2-positive metastatic breast cancer, specific metastatic cases presenting with HER2-low and HER2-ultralow expression.
Pre-treated HER2-positive gastric or gastroesophageal junction adenocarcinomas.
Select pre-treated, unresectable HER2-positive solid tumors lacking viable alternative therapies.
With this clearance, AstraZeneca broadens its targeted oncology portfolio, offering a new standard for early metastatic intervention in India.