AstraZeneca Pharma India gains CDSCO permission for Enhertu in HER2-positive solid tumours

Written By :  Ruchika Sharma
Published On 2025-10-04 05:57 GMT   |   Update On 2025-10-04 05:57 GMT
Advertisement

Bangalore: AstraZeneca Pharma India Limited has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India to import for sale and distribution of Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu) for an additional indication.

Through this approval, Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

Advertisement

The receipt of this permission paves way for the marketing of Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion (Brand name: Enhertu) in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.

In May, the company received CDSCO approval for Enhertu as a monotherapy for the treatment of adult patients with unresectable or metastatic HER2- low (IHC 1+ and IHC 2+/ISH-) or HER2- ultralow (IHC0 with membrane staining) breast cancer, who have received at least one endocrine therapy in metastatic setting.

Read also: AstraZeneca Pharma India gets CDSCO approval for Enhertu for new breast cancer indication

Last year in March, AstraZeneca Pharma India Limited received permission to import for sale and distribution of Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100mg from the CDSCO for the treatment of adult patients with unresectable or metastatic HER2-Low breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. The approval also covered the treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab based regimen.

AstraZeneca India was established in 1979 and is headquartered at Bengaluru, Karnataka. AstraZeneca Pharma India Limited is the operating company and covers manufacturing, sales and marketing activities of the company in India.

It is a listed company and is a subsidiary of AstraZeneca Plc, UK.

Tags:    

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News