AstraZeneca receives CDSCO approval for Enhertu followed by THP for adults with HER2-positive stage II or III early Breast cancer

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28 July 2026: AstraZeneca receives CDSCO approval for Enhertu followed by THP for adults with HER2-positive stage II or III early Breast cancer

AstraZeneca Pharma India announced that the Central Drugs Standard Control Organisation has approved Enhertu followed by THP (taxane, trastuzumab and pertuzumab) as neoadjuvant therapy for adults with HER2-positive (IHC 3+ or ISH+) stage II/III early breast cancer, marking the first approval of this regimen in India
The approval is supported by the global phase 3 DESTINY-Breast11 trial, in which Enhertu followed by THP demonstrated a statistically significant improvement in pathologic complete response versus ddAC-THP, with an absolute pCR difference of 11.2% in patients with HER2-positive Stage II/III early breast cancer
The approval addresses an important unmet need in early HER2-positive breast cancer by introducing a more effective neoadjuvant strategy aimed at increasing the likelihood of complete tumor eradication before surgery and improving long-term clinical outcomes for patients at high risk of recurrence
Enhertu is a HER2-directed antibody-drug conjugate that couples trastuzumab with a cleavable linker and a potent DXd topoisomerase I inhibitor payload, enabling targeted intracellular delivery of chemotherapy while providing a bystander antitumor effect against heterogeneous HER2-expressing tumors
Strategically, this approval expands Enhertu’s footprint in India from metastatic to early-stage HER2-positive breast cancer, reinforcing AstraZeneca and Daiichi Sankyo’s strategy of moving the HER2 ADC into earlier treatment settings and strengthening its position as a cornerstone therapy across the breast cancer continuum