AstraZeneca Pharma gets nod to import for sale, distribution of Trastuzumab deruxtecan lyophilized powder

27 Mar 2024 Evaluate

AstraZeneca Pharma India has received permission to import for sale and distribution of Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100mg (Enhertu) from the Central Drugs Standard Control Organisation, Directorate General of Health Services, Government of India. 

Trastuzumab deruxtecan is indicated for the treatment of adult patients with unresectable or metastatic HER2-Low (IHC 1+ or IHC 2+/ISH-) 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.

It is also indicated for 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.

The receipt of this permission paves way for the launch of Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100mg (Enhertu) in India for the specified additional indications, subject to the receipt of related statutory approvals, if any.

AstraZeneca Pharma India is a global biopharmaceutical company. The company is engaged in the discovery, development and commercialization of medicines for core areas of healthcare, including cardiovascular/metabolic disease, cancer and respiratory, inflammatory and autoimmune disease. The company operates through two segments Healthcare and Clinical Trial.

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