AstraZeneca Pharma India received approval from India's Central Drugs Standard Control Organization for Enhertu, a smart chemotherapy brand. The drug will be used in combination with pertuzumab for adults with unresectable or metastatic HER2-positive breast cancer.
The regulatory approval in India expands treatment options for HER2-positive breast cancer patients and strengthens AstraZeneca's market presence in a key region.
AstraZeneca Pharma India Ltd announced on Thursday that it has received regulatory approval from India's Central Drugs Standard Control Organization (CDSCO) to import, sell, and distribute its chemotherapy drug Enhertu.
The approval, granted on June 10, allows for the use of Enhertu (Trastuzumab deruxtecan 100 mg/5mL) in combination with pertuzumab as a first-line treatment for adults diagnosed with unresectable or metastatic HER2-positive breast cancer. HER2-positive breast cancer is characterized by the overexpression of the HER2 protein on tumor cells, making it a faster-growing subtype that affects approximately one in five breast cancer patients globally.
This expanded indication is expected to provide oncologists and patients with enhanced treatment options, as therapies specifically targeting HER2 have proven effective.
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