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, Government of India.
Through this approval, Trastuzumab deruxtecan (Enhertu) 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 receipt of this permission paves way for the launch of Trastuzumab deruxtecan (Enhertu) solution of 100mg/5mL in India for the specified indication, subject to the receipt of related statutory approvals.
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.
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.”
