India | Drug Approvals | Pharma News | 2024 | iPharmaCenter

January 03, 2024

AstraZeneca India Unveils Trastuzumab Deruxtecan for HER2-Positive Metastatic Cases

AstraZeneca India has officially launched trastuzumab deruxtecan, a specialized intervention devised for the management of adult patients grappling with unresectable or metastatic HER2 positive breast cancer, initiating from January 2024. This inventive treatment, co-created with Daiichi Sankyo, incorporates a HER2-targeted antibody-drug conjugate (ADC).

Breast cancer stands as a noteworthy global health issue, with over 2 million instances documented in 2020, establishing it as the most identified cancer according to the World Health Organization (WHO). In India, there has been a significant 40% uptick in the frequency of breast cancer over the past 25 years. Trastuzumab deruxtecan marks a substantial leap in addressing the vital medical requirements of patients contending with HER2-positive metastatic breast cancer.

The initiation of trastuzumab deruxtecan is supported by affirmative outcomes from the DESTINY-Breast03 trial, a worldwide Phase III investigation. The primary findings, disclosed in The New England Journal of Medicine, suggest an impressive 72% reduction in the hazard of ailment progression or demise compared to trastuzumab emtansine (T-DM1). Updated outcomes, published in The Lancet, indicate a 36% decrease in the threat of demise versus T-DM1. Significantly, 77.4% of patients treated with trastuzumab deruxtecan survived at the two-year mark, spotlighting the enduring impact of this pioneering therapy across diverse patient subdivisions. The median progression-free survival, as ascertained by an impartial central review, was a noteworthy 28.8 months with trastuzumab deruxtecan in contrast to 6.8 months with T-DM1, reinforcing its standing as a transformative intervention in breast cancer care.

AstraZeneca India stated that this therapy brings reinvigorated optimism and enhanced consequences for patients grappling with HER2-positive metastatic breast cancer. The Drug Controller General of India (DCGI) granted authorization for the import and promotion of trastuzumab deruxtecan to AstraZeneca India in May 2023.