AstraZeneca Gets CDSCO Nod to Market Enhertu for New Breast Cancer Indication
Bengaluru: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, to import for sale and distribution Trastuzumab Deruxtecan 100 mg/5 mL lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu) for an additional indication in India.
According to the company, Enhertu (Trastuzumab Deruxtecan) 100 mg is now indicated for the adjuvant treatment of adult patients with HER2-positive (IHC 3+ or ISH+) breast cancer who have residual invasive disease following neoadjuvant Trastuzumab (with or without Pertuzumab) and taxane-based treatment.
The approval enables AstraZeneca Pharma India to market Trastuzumab Deruxtecan 100 mg/5 mL in the country for the newly approved indication, subject to the receipt of any related statutory approvals that may be required.
Enhertu is a targeted therapy used in the treatment of HER2-positive cancers and is designed to deliver chemotherapy directly to cancer cells while limiting exposure to healthy tissues. The newly approved indication expands its use in patients who continue to have residual invasive disease after receiving neoadjuvant HER2-directed therapy and taxane-based chemotherapy.
