AstraZeneca Pharma India Ltd., a science-led biopharmaceutical company, on Wednesday announced that it has received approval from the Drug Controller General of India (DCGI) for the cancer drug Trastuzumab Deruxtecan for the treatment of metastatic breast cancer.

Trastuzumab Deruxtecan is a specifically engineered HER2-directed antibody-drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo. AstraZeneca has received import and marketing permission in Form CT-20 from the regulator, and the therapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.

The India approval is based on a global, head-to-head, randomised, open-label, registrational Phase III trial of DESTINY Breast 03. Globally, Trastuzumab Deruxtecan is approved in more than 40 countries, including the US, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

The HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumours including breast, gastric, lung and colorectal cancers, and is one of the biomarkers expressed in breast cancer tumours.

Dr Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said, “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. India’s approval of Trastuzumab Deruxtecan marks a significant clinical advancement allowing us to help more patients across the HER2 spectrum. It also supports our ambition to evolve the way breast cancer is classified and treated in the country, to ultimately improve patient outcomes. We will continue our thrust on global clinical trials to eliminate cancer as a cause of death and bring transformative therapies to India, thereby reducing the disease burden on our healthcare systems.”

Dr Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, said, “Trastuzumab Deruxtecan has demonstrated significantly improved overall survival and progression-free survival outcomes in patients with HER2-positive metastatic breast cancer in DESTINY Breast 3 trial.

According to World Health Organisation, more than 2 million cases of breast cancer were diagnosed in 2020, making it the world’s most commonly diagnosed cancer. The incidence of breast cancer is low in India, but it is gradually rising with almost a 40 per cent increase in cases, over the past 25 years.