AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization to import and distribute Trastuzumab Deruxtecan (Enhertu®) for an additional indication. This approval allows for the marketing of Enhertu® for the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following specific prior treatments, opening up a significant new market segment.
Enhertu® Approved for Additional Breast Cancer Indication
AstraZeneca Pharma India Limited announced on August 7, 2026, that it has secured permission from the Central Drugs Standard Control Organization (CDSCO), Government of India. This authorization permits the import, sale, and distribution of Trastuzumab Deruxtecan 100mg/5mL lyophilized powder for concentrate for solution for infusion, marketed under the brand name Enhertu®, for a new, additional indication.
New Indication Focus
The newly approved indication specifies that Enhertu® is now indicated for the adjuvant treatment of adult patients diagnosed with HER2-positive (IHC 3+ or ISH+) breast cancer. This applies to patients who exhibit residual invasive disease after undergoing neoadjuvant treatment that included Trastuzumab (with or without Pertuzumab) and taxane-based therapies. This expanded approval aims to address a critical need in the treatment of early-stage breast cancer with specific characteristics.
Market Access and Future Prospects
The receipt of this permission is a significant step forward, enabling the marketing of Enhertu® in India for this specific additional indication. This paves the way for wider patient access to the therapy, subject to any further related statutory approvals that may be required. The company views this as a crucial development in its commitment to advancing cancer care in India.
Source: BSE
