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, effective June 10, 2026, allows Enhertu® in combination with pertuzumab for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. This paves the way for marketing the drug for this specific use in India.
Key Regulatory Approval Secured
On June 10, 2026, AstraZeneca Pharma India Limited announced that it has secured a significant approval from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India. This permission grants the company the authorization to import for sale and distribution of Trastuzumab deruxtecan, marketed under the brand name Enhertu®. The approval is for an additional indication for the drug, which is supplied as a 100 mg/5mL vial lyophilized powder for concentrate for solution for infusion.
Enhanced Treatment Option for Breast Cancer
The newly approved indication for Enhertu® involves its use in combination with pertuzumab. This combination therapy is now indicated for the first-line treatment of adult patients diagnosed with unresectable or metastatic HER2-positive (IHC3+ or ISH+) breast cancer. This advancement provides a new and potentially more effective treatment option for patients in India battling this specific type of breast cancer.
Market Expansion and Future Steps
The receipt of this permission is a crucial step that enables AstraZeneca to proceed with the marketing of Enhertu® for the specified additional indication in India. The company notes that this is subject to the receipt of any further related statutory approvals that may be required. AstraZeneca has formally communicated this development to the stock exchanges, requesting that the intimation be taken on record.
Source: BSE
