AZN, Daiichi's Enhertu Gets FDA Nod for First-Line Breast Cancer

Core Insights - AstraZeneca and Daiichi Sankyo received FDA approval for Enhertu as a first-line treatment for HER2-positive breast cancer, in combination with Roche's Perjeta [2][7] - The approval is based on the DESTINY-Breast09 study, which showed a significant improvement in progression-free survival [5][7] - AstraZeneca will pay Daiichi Sankyo a $150 million milestone payment following this approval [3][7] Regulatory and Clinical Data - Enhertu was reviewed under the FDA's real-time oncology review program and is already approved in over 85 countries for second-line treatment of HER2-positive breast cancer [3] - The DESTINY-Breast09 study demonstrated a median progression-free survival of 40.7 months for the Enhertu-Perjeta combination, compared to 26.7 months for the standard regimen, reducing the risk of progression by 44% [5][7] Financial Performance - Over the past year, AstraZeneca's shares increased by 36.3%, outperforming the industry average rise of 12.1% [4] - AstraZeneca and Daiichi Sankyo have a collaboration agreement initiated in March 2019, with an expansion in July 2020 to include Datroway [8]