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

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 concentrate for solution for infusion 100 mg [Brand name: ENHERTU] for an additional indication.

Through this approval, Enhertu is indicated 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.

The receipt of this permission paves way for the marketing of Trastuzumab deruxtecan concentrate for solution for infusion 100 mg [Brand name: ENHERTU] in India for the specified additional indication, subject to the receipt of related statutory approvals, if any.

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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.

Read also: AstraZeneca India bags dual CDSCO nod for Trastuzumab deruxtecan