Key Highlights:
- AstraZeneca has received CDSCO approval for an additional indication of Enhertu (trastuzumab deruxtecan) in combination with Perjeta (pertuzumab) as a first-line treatment for adults with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer. The approval introduces a new first-line treatment option for a patient population with significant unmet need, particularly as many patients do not progress to subsequent lines of therapy.
- The approval is supported by results from the DESTINY-Breast09 trial, which included patients from India. In the study, Enhertu plus Perjeta achieved a median progression-free survival (PFS) of 40.7 months, compared with 26.9 months for the standard THP regimen (taxane, trastuzumab, and pertuzumab). The combination reduced the risk of disease progression or death by 44%, with benefits observed consistently across patient subgroups.
- ER2-positive disease accounts for approximately 12%–19% of breast cancer case in India and is among the most aggressive breast cancer subtypes. The new indication expands Enhertu’s use beyond its existing approvals in previously treated HER2-positive breast cancer, HER2-low and HER2-ultralow breast cancer, HER2-positive gastric cancers, and certain other HER2-positive solid tumors, further strengthening AstraZeneca’s oncology portfolio in India.
Implications:
This approval moves Enhertu + Perjeta into the front line of HER2‑positive metastatic breast cancer care in India, displacing taxane + trastuzumab + pertuzumab (THP) as the reference regimen for many eligible patients. Given that HER2‑positive disease represents a sizable and aggressive subset of Indian breast cancers, many of whom never reach second‑line therapy, shifting this antibody‑drug conjugate into first line should capture more patients earlier, drive substantial uptake for AstraZeneca/Daiichi Sankyo, and further entrench Enhertu as a backbone HER2 therapy across multiple tumors in the Indian oncology market.
Source: AstraZeneca
