The cancer medicine Trastuzumab Deruxtecan has been approved by the medicine Controller General of India (DCGI), according to AstraZeneca Pharma India Ltd., a science-driven biopharmaceutical firm, which made the announcement on Wednesday.
AstraZeneca and Daiichi Sankyo are working together to develop and market Trastuzumab Deruxtecan, an antibody-drug combination (ADC) that is precisely tailored to target the HER2 gene. The medicine is intended for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have previously undergone an anti-HER2-based regimen and has acquired import and marketing authorisation in Form CT-20 from the regulator.
The DESTINY Breast 03 Phase III global head-to-head, randomised, open-label, registrational study served as the foundation for the India clearance. More than 40 nations throughout the world, including the US, have authorised the use of trastuzumab deruxtecan for the treatment of adult patients with metastatic or unresectable HER2-positive breast cancer.
One of the biomarkers found in breast cancer tumours is HER2, a tyrosine kinase receptor growth-promoting protein that is expressed on the surface of a variety of tumours, including breast, gastric, lung, and colorectal cancers.
“AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death, and as part of this, we are continuously following the science and working to deliver life-changing medicines to patients,” said Dr. Sanjeev Panchal, Country President and Managing Director, AstraZeneca India. Trastuzumab Deruxtecan’s approval in India is a substantial clinical development that will enable us to assist more patients across the HER2 spectrum. Additionally, it supports our goal of modernising the nation’s classification and management of breast cancer in order to enhance patient outcomes. We will keep working to reduce the burden of sickness on our healthcare systems by focusing on global clinical trials to end cancer as a cause of death and introduce breakthrough treatments to India.
Trastuzumab Deruxtecan has shown substantially better overall survival and progression-free survival outcomes in patients with HER2-positive metastatic breast cancer in the DESTINY Breast 3 trial, according to Dr. Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India.
Breast cancer was the most often diagnosed cancer in the world in 2020, with more than 2 million cases being reported, according to the World Health Organisation. In India, the incidence of breast cancer is modest, but it has been steadily increasing over the last 25 years, with a nearly 40% rise in cases.
