AstraZeneca Pharma India has received a key regulatory clearance that marks an important step in expanding advanced oncology treatment options in the country. The company has announced that it has obtained permission from the Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, to import Datopotamab Deruxtecan for sale and distribution in India.
The approval covers Datopotamab Deruxtecan powder for concentrate for solution for infusion, 100 mg (r-DNA origin), which will be marketed under the brand name Datverzo. This therapy is classified as a new drug in India and represents a novel treatment option in the breast cancer segment.
According to the regulatory approval, Datverzo is indicated for the treatment of adult patients with unresectable or metastatic breast cancer that is hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative. This includes patients with HER2 IHC 0, IHC 1+, or IHC 2+/ISH-negative status. The drug is specifically approved for patients who have already received prior endocrine-based therapy as well as chemotherapy for unresectable or metastatic disease.
