AstraZeneca’s Datverzo Gets CDSCO Approval for Advanced Breast Cancer Treatment

AstraZeneca Pharma India has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) to import and market Datopotamab Deruxtecan, a new cancer therapy, under the brand name Datverzo, in India. The drug, indicated as Datverzo 100mg powder for infusion (r-DNA origin), is approved for adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have previously received endocrine-based therapy and chemotherapy. It is specifically suited for patients with tumor classifications of IHC 0, IHC 1+, or IHC 2+/ISH-. This approval marks a significant advancement in targeted oncology care, offering a new treatment option for patients with limited therapeutic alternatives after standard treatments. While commercial launch awaits any additional statutory clearances, the nod underscores AstraZeneca’s commitment to expanding access to innovative, precision-driven cancer therapies in India. Datverzo’s introduction highlights progress in addressing unmet needs in advanced breast cancer management.