AstraZeneca Pharma India Limited has secured approval from the Central Drugs Standard Control Organization (CDSCO) for Trastuzumab deruxtecan to be used in two additional indications.

The lyophilized powder form of the drug has now been given the green light for the treatment of adult patients with unresectable or metastatic HER2-Low breast cancer post-chemotherapy, as well as for individuals with HER2-positive gastric or gastroesophageal cancer following a trastuzumab-based regimen.

 Previously, its authorization was limited to metastatic HER2-positive breast cancer patients who had undergone prior anti-HER2 therapy.

Breast cancer, as highlighted by the World Health Organization (WHO), surpassed 20 lakhs in global cases in 2020. In India, it stands as the most prevalent cancer among women, constituting over 25 percent of all female cancer cases.

The five-year age-standardized relative survival rate for breast cancer patients is estimated at 66.4 percent, with variations across different regions. Over the past 25 years, there has been a notable surge in cases, with a 40 percent increase in incidence.

Gastric cancer ranks as the sixth most common cancer affecting Indian men. It poses a significant challenge, with a five-year survival rate of less than seven percent for advanced-stage diagnoses. The incidence of gastric cancer has shown a gradual rise over the past decade.

Dr. Sanjeev Panchal, Country President and Managing Director of AstraZeneca India, expressed, “The approval of Trastuzumab deruxtecan marks a critical stride in addressing unmet medical needs and offering transformative treatments to Indian patients.

This approval holds the potential to substantially enhance outcomes for those grappling with advanced or metastatic low HER-2 and HER-positive gastric cancers, who have exhausted other treatment options. Our objective is to revolutionize cancer care, elevate patient outcomes, and ultimately eradicate cancer as a leading cause of mortality. We are steadfast in our commitment to innovation, collaboration, and expediting access to vital medications.”

Dr. Anil Kukreja, Vice-President of Medical Affairs and Regulatory at AstraZeneca India, elaborated, “Trastuzumab deruxtecan has demonstrated significant advancements in overall and progression-free survival for HER2-low metastatic breast cancer in the DESTINY Breast 04 trial. The DESTINY Gastric 02 trial has affirmed its efficacy as a second-line therapy for HER2-positive advanced gastric or gastroesophageal junction cancer. These robust clinical trial findings underscore our ongoing endeavors to revolutionize cancer care.”