AstraZeneca Pharma India Limited 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, expanding treatment options for patients with HER2-positive breast cancer.

The approval allows Trastuzumab Deruxtecan, followed by a taxane, trastuzumab and pertuzumab (THP), to be used as neoadjuvant therapy for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer.

The company said the approval paves the way for the marketing of Enhertu in India for the newly approved indication, subject to receipt of any other applicable statutory approvals.

Enhertu is a lyophilized powder for concentrate for solution for infusion and is jointly developed by AstraZeneca and Daiichi Sankyo. 

The latest approval further expands its clinical use in India, where the therapy is already approved for multiple HER2-targeted oncology indications.