CDSCO Approves AstraZeneca's Enhertu for Neoadjuvant HER2-Positive Breast Cancer
New Delhi: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services (DGHS), Government of India, to import, market and distribute Trastuzumab Deruxtecan 100 mg/5 mL lyophilized powder for concentrate for solution for infusion (Enhertu) for an additional indication in India.
According to the company, the newly approved indication allows trastuzumab deruxtecan, followed by a taxane, trastuzumab and pertuzumab (THP), to be used as neoadjuvant treatment for adult patients with HER2-positive (IHC 3+ or ISH+) Stage II or Stage 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.
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