AstraZeneca Pharma India has received permission from the Central Drugs Standard Control Organisation (CDSCO)to import for sale and distribution of Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100 mg (Enhertu) for two additional indications.
HER2-low metastatic breast cancer and HER2 positive gastric / gastro-oesophageal cancer are the additional indications for which CDSCO has given approval, the company said recently.
“With this approval, we have the potential to significantly enhance outcomes for patients battling advanced or metastatic low HER-2 and HER-positive gastric cancers, especially those who have exhausted standard treatment options,” country president and MD Sanjeev Panchal said. The Drugs Controller General of India (DCGI) had earlier approved Trastuzumab deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.
The latest permission paves way for launch of Trastuzumab deruxtecan lyophilized powder for concentrate for solution for infusion 100mg (Enhertu) in India for the specified additional indications, subject to receipt of related statutory approvals, if any, the company said.
