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.
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.
