AstraZeneca Pharma India Ltd. 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 pharma major said in a statement.
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.
“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. Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said in a statement.
According to World Health Organisation (WHO), 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 percent increase in cases, over the past 25 years.
However, there remain significant gaps in access to as well as inequality in cancer care. Awareness and timely screening remain crucial for positive clinical outcomes and almost 60 percent cases are diagnosed at an advanced stage.
