AstraZeneca Pharma India gets CDSCO nod to import and market datverzo breast cancer drug

Drug firm AstraZeneca Pharma India Ltd on Wednesday (December 17) said it has received permission from the Central Drugs Standard Control Organisation, Directorate General of Health Services, to import datopotamab deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin), marketed under the brand name Datverzo.

The approval is for sale and distribution in India and marks the introduction of a new drug in the country.

Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) is indicated for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

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The indication covers patients classified as IHC 0, IHC 1+ or IHC 2+/ISH- who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The company said the receipt of permission from the CDSCO paves the way for the marketing of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100 mg (r-DNA origin) under the brand name Datverzo in India for the specified indication. The marketing of the drug will be subject to the receipt of related statutory approvals, if any.

Shares of Astrazeneca Pharma India Ltd ended at ₹8,984.50, down by ₹32.00, or 0.35%, on the BSE.

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