By: IPP Bureau
Last updated : August 08, 2026 4:56 pm
The latest approval expands the treatment options available to eligible patients with HER2-positive breast cancer in India, covering both earlier and advanced stages of the disease
AstraZeneca Pharma India Ltd. (AZPIL) announced that the Central Drugs Standard Control Organisation (CDSCO) has approved an additional indication for trastuzumab deruxtecan 100 mg/5 mL vial lyophilised powder for concentrate for solution for infusion.
The approval covers the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant trastuzumab, with or without pertuzumab, and taxane-based treatment.
Trastuzumab deruxtecan is already approved in India for specified settings in metastatic HER2-positive breast cancer, including in combination with pertuzumab in the first-line setting.
It is also approved for HER2-low and HER2-ultralow metastatic breast cancer, neoadjuvant treatment of early breast cancer, locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma, and other unresectable or metastatic HER2-positive (IHC3+) solid tumours after prior systemic treatment where no satisfactory alternative treatment options exist.
The CDSCO approval is supported by results from the DESTINY-Breast05 trial. In the study, post-neoadjuvant trastuzumab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (IDFS) compared with T-DM1, reducing the risk of invasive disease or death by 53% (HR 0.47; 95% CI 0.34, 0.66; p<0.0001).
The study also demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) versus T-DM1. According to the company, efficacy benefits were consistent across all prespecified subgroups for both IDFS and DFS.
Praveen Rao Akkinepally, Country President and Managing Director, AstraZeneca Pharma India Limited said, “At AstraZeneca, our purpose is to push the boundaries of science to deliver life-changing medicines, and we are committed to bringing important innovations to patients in India as early as possible.”
“For patients with HER2-positive early breast cancer who have residual disease after neoadjuvant treatment, the possibility of recurrence can continue to affect long-term outcomes despite existing treatment options. This approval helps address that need by expanding access to a new adjuvant treatment option for eligible patients in India,” added Akkinepally.
HER2-positive breast cancer accounts for approximately 21% of breast cancer cases. In the early-stage setting, this includes Stage I-III disease confined to the breast and/or regional lymph nodes and characterised by HER2 overexpression or amplification.
For patients who do not achieve a pathological complete response (pCR) following neoadjuvant treatment, the risk of recurrence remains a significant clinical concern.
While adjuvant T-DM1 is recommended for high-risk patients with residual disease following neoadjuvant treatment and surgery, unmet need remains, particularly among patients with advanced locoregional disease or positive nodal status.