AstraZeneca Pharma India Limited on Thursday said it will launch Trastuzumab Deruxtecan, also known as Enhertu, which is used in the treatment of HER2-positive breast cancer, in January 2024.
The company received clearance from the Central Drugs Standard Control Organisation (CDSCO) to import and sell Enhertu in May 2023.
“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.
All you need to know about Enhertu
Enhertu, an antibody-drug conjugate, is being used in the treatment of HER2-positive metastatic breast cancer in several countries globally. It received clearance from the European Union’s (EU’s) drug regulator in January this year.
In a recent trial, Enhertu showed clinically meaningful and durable responses across multiple HER2-expressing tumour types, said AztraZeneca, the UK-headquartered parent entity of AstraZeneca Pharma, in a release issued in March.
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.