AstraZeneca's trastuzumab deruxtecan approved by CDSCO for adults with HER2-positive Stage II or III early breast cancer | iPharmaCenter

AstraZeneca Pharma India secured a significant regulatory expansion from the Central Drugs Standard Control Organisation (CDSCO) for trastuzumab deruxtecan. The approval covers the 100 mg/5 mL presentation of the drug for use in a neoadjuvant regimen, administered prior to surgical intervention, for adult patients diagnosed with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer.

This treatment protocol involves the administration of trastuzumab deruxtecan followed by a regimen of taxane, trastuzumab, and pertuzumab (THP).

The authorization of this neoadjuvant pathway is anchored in evidence from the DESTINY-Breast11 clinical trial. The study demonstrated a statistically significant and clinically meaningful improvement in pathological complete response (pCR) rates compared to the control group (ddAC-THP). Results showed an absolute pCR difference of 11.2% (95% confidence interval: 4.0 to 18.3).

Notably, this benefit persisted across various patient subgroups, regardless of hormone receptor status or specific disease stage. This regulatory update addresses a long-standing clinical gap, as no new therapies have been introduced for the neoadjuvant HER2-positive setting in over a decade, leaving previous standards of care to struggle with pCR rates typically ranging between 39% and 64%.

The introduction of high-potency biologics into the neoadjuvant treatment landscape is expected to alter the current oncology delivery model.

For over ten years, the treatment of early-stage HER2-positive breast cancer has remained largely static, often necessitating chemotherapy-heavy regimens that carry significant acute and long-term toxicity risks. The inclusion of trastuzumab deruxtecan sets a new efficacy benchmark, compelling competitors to re-evaluate their pipelines against this elevated pCR threshold.

Trastuzumab deruxtecan maintains existing approvals in India for metastatic HER2-positive, HER2-low, and HER2-ultralow breast cancer, as well as specific gastric and solid tumor indications.