AstraZeneca Pharma India Ltd. (AZPIL) has received permission from the Central Drugs Standard Control Organization (CDSCO) to import and market Enhertu (trastuzumab deruxtecan) 100 mg/5 mL for an additional indication in India.
Under the expanded approval, trastuzumab deruxtecan followed by a taxane, trastuzumab and pertuzumab (THP) can now be used as neoadjuvant treatment for adults with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer.
The approval enables AstraZeneca to market Enhertu for this new indication in India, subject to any remaining statutory clearances.
Enhertu is a HER2-directed antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
The latest approval follows the CDSCO’s June 2026 authorization of Enhertu in combination with pertuzumab as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer.
The approval was supported by data from the DESTINY-Breast09 trial, which included Indian patients. In the study, the combination of trastuzumab deruxtecan and pertuzumab significantly improved progression-free survival (PFS) compared with the standard THP regimen (taxane, trastuzumab and pertuzumab).
Patients receiving the Enhertu combination achieved a median PFS of 40.7 months, compared with 26.9 months for those receiving THP, translating into a 44% reduction in the risk of disease progression or death. The benefit was consistent across all patient subgroups.
Commenting on the earlier approval, Praveen Rao Akkinepally, country president and managing director of AZPIL, said, “This approval marks an important step forward for patients with unresectable or metastatic HER2-positive breast cancer in India, where the need for more effective treatment options in the first-line setting remains high. For many patients, the initial treatment decision can shape outcomes across the course of their disease, making early access to innovation especially important.”
Separately, AstraZeneca and Daiichi Sankyo’s Enhertu, in combination with pertuzumab, was recently recommended for approval in the European Union by the Committee for Medicinal Products for Human Use (CHMP) for the first-line treatment of adults with unresectable or metastatic HER2-positive breast cancer.
Currently, trastuzumab deruxtecan is approved for multiple indications, including previously treated unresectable or metastatic HER2-positive breast cancer, HER2-low and HER2-ultralow metastatic breast cancer in eligible patients, HER2-positive gastric or gastroesophageal junction adenocarcinoma after a prior anti-HER2-based regimen, and certain other unresectable or metastatic HER2-positive solid tumours where no satisfactory alternative treatment options are available.
Breast cancer burden in India
Breast cancer is the most commonly diagnosed cancer among women worldwide, with HER2-positive disease representing one of its more aggressive forms. In India, HER2-positive breast cancer accounts for an estimated 12% to 19% of all breast cancer cases, as reported by AstraZeneca.
Despite progress in treatment, significant unmet need remains in the metastatic setting. No new first-line therapies had significantly improved outcomes for HER2-positive metastatic breast cancer in recent years, and nearly one-third of patients receiving first-line treatment do not proceed to second-line therapy, underscoring the importance of effective treatment early in the disease course.
