AstraZeneca Pharma India Limited announced that it has received permission from the Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Government of India, to import and market Trastuzumab Deruxtecan (brand name: Enhertu) in the country for an additional indication.
The new approval allows the use of Enhertu, supplied as a 100mg/5mL vial lyophilized powder for infusion, in the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors. The therapy is indicated for patients who have already received prior systemic treatment and have no satisfactory alternative treatment options available.
Trastuzumab Deruxtecan, co-developed globally by AstraZeneca and Daiichi Sankyo, is recognized as an important targeted therapy in oncology. By gaining approval for this additional indication in India, AstraZeneca will be able to offer more treatment choices to patients facing advanced-stage cancers with limited options.
The receipt of this approval paves the way for the company to market Enhertu for the specified indication, subject to the completion of further statutory clearances, if any. This development is expected to strengthen AstraZeneca Pharma India’s oncology portfolio and reinforce its commitment to addressing unmet medical needs in cancer care.
