AstraZeneca Pharma Gets CDSCO Nod To Import Breast Cancer Drug For Wider Use

AstraZeneca Pharma India Ltd. on Thursday said it has received approval from the Central Drugs Standard Control Organisation to import Trastuzumab deruxtecan concentrate solution for infusion in 100 mg strength for an additional indication.

The drug is now also approved as a monotherapy for treating adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, who have received at least one endocrine therapy in the metastatic setting, the company said in a filing.

AstraZeneca can market the drug in India for the additional indication after receiving other required statutory approvals.