- AstraZeneca India got CDSCO approval for Trastuzumab Deruxtecan's new breast cancer use
- Enhertu targets HER2-positive breast cancer with residual invasive disease after prior treatments
- Approval covers patients with HER2-positive tumors classified as IHC 3+ or ISH+
AstraZeneca Pharma India Ltd. on Saturday said it has received permission from the Central Drugs Standard Control Organisation to import, sell and distribute Trastuzumab Deruxtecan for an additional breast cancer indication in India.
The approval covers Trastuzumab Deruxtecan 100 mg/5 mL lyophilised powder for concentrate for solution for infusion, sold under the brand name Enhertu, the company said in an exchange filing.
Enhertu is a prescription cancer medicine used to treat certain types of breast, lung and stomach cancers that have the HER2 protein. It is a targeted treatment that finds HER2-positive cancer cells and delivers chemotherapy directly to them.
Enhertu is now indicated for the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab, with or without pertuzumab, and taxane-based treatment.
The approval applies to patients whose tumours are HER2-positive, classified as IHC 3+ or ISH+.
AstraZeneca Pharma said the permission from the Central Drugs Standard Control Organisation, under the Directorate General of Health Services, Government of India, paves the way for marketing Enhertu in India for the additional indication. The launch will be subject to receipt of any other applicable statutory approvals, the company said.
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AstraZeneca Pharma Earnings
The Board of Directors of AstraZeneca Pharma India will be held on Monday, August 10, 2026 to consider and approve the Un-audited Financial Results of the Company for the quarter ended June 30, 2026.
The company said that the Trading Window will remain closed for all Designated Persons, from June 16, 2026 to August 12, 2026 (both days inclusive) in terms of AstraZeneca Pharma India Limited - Code of Conduct for Prevention of Insider Trading framed under Securities and Exchange Board of India (Prohibition of Insider Trading) Regulations 2015.
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