AstraZeneca Pharma India Limited has obtained CDSCO approval for Trastuzumab deruxtecan for two new uses. The lyophilized powder form of the drug is now approved for treating adult patients with unresectable or metastatic HER2-Low breast cancer post-chemotherapy, and for those with HER2-positive gastric or gastroesophageal cancer following a trastuzumab-based regimen. Previously, it was authorized for metastatic HER2-positive breast cancer patients who had prior anti-HER2 therapy.
According to the World Health Organisation (WHO), breast cancer cases exceeded 20 lakhs in 2020 globally. It is the most common cancer among Indian women, accounting for over 25 percent of all female cancers. The five-year age-standardized relative survival rate for breast cancer patients is estimated to be 66.4 percent, with variations across different regions. There has been a significant increase in cases over the past 25 years, with a 40 percent rise in incidence.
Gastric cancer is the sixth most prevalent cancer affecting Indian men. It presents a considerable challenge with a 5-year survival rate of less than seven percent for advanced-stage diagnoses. The incidence of gastric cancer has shown a gradual increase over the past decade.
Dr Sanjeev Panchal, Country President and Managing Director, AstraZeneca India, said, “The approval of Trastuzumab deruxtecan marks a critical step in meeting unmet medical needs and offering transformative treatments to Indian patients. This approval could greatly improve outcomes for those with advanced or metastatic low HER-2 and HER-positive gastric cancers who have no other treatment options. Our goal is to revolutionize cancer care, enhance patient outcomes, and ultimately eliminate cancer as a leading cause of death. We’re committed to innovation, collaboration, and fast-tracking access to crucial medications.”
Dr Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, said, “Trastuzumab deruxtecan has shown significant improvements in overall and progression-free survival for HER2-low metastatic breast cancer in the DESTINY Breast 04 trial. The DESTINY Gastric 02 trial confirmed its effectiveness as a second-line therapy for HER2-positive advanced gastric or gastroesophageal junction cancer. These strong clinical trial results reflect our ongoing efforts to transform cancer care.”
