India Pharma Outlook Team | Friday, 22 December 2023
As per AstraZeneca Pharma India Limited, Trastuzumab Deruxtecan, also known as Enhertu, will be accessible in January 2024 for the treatment of HER2-positive breast cancer.
The company received clearance from the Central Drugs Standard Control Organisation (CDSCO) to import and sell Enhertu in May 2023, as per business standard.
“AstraZeneca Pharma India has received a permission in Form CT-20 to import for sale and distribution of Trastuzumab Deruxtecan [Enhertu] 100mg/5mL vial lyophilized powder for concentrate for solution for infusion from the Central Drugs Standard Control Organisation, Directorate General of Health Services," the company had said in a press release.
Enhertu, an antibody-drug conjugate, is being used to treat HER2-positive metastatic breast cancer in a number of countries throughout the world. The European Union's (EU) drug agency approved it in January of this year.
According to AztraZeneca, the UK-headquartered parent entity of AstraZeneca Pharma, Enhertu revealed clinically significant and durable responses across diverse HER2-expressing tumor types in a recent trial.
The drug “met the prespecified target for objective response rate and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pretreated patients,” it noted.
The headquarters of the Anglo-Swedish multinational pharmaceutical and biotechnology business AstraZeneca plc are located in Cambridge, England's Cambridge Biomedical Campus. Its product line includes treatments for serious illnesses in the fields of oncology, inflammation, infection, neurology, gastrointestinal disorders, and respiratory disorders. It contributed to the Oxford-AstraZeneca COVID-19 vaccine's development.