AZN, Daiichi's Enhertu Gets Breakthrough Tag for Expanded Cancer Use

Core Insights - The FDA has granted Breakthrough Therapy designation to AstraZeneca and Daiichi Sankyo's Enhertu for expanded use in treating HER2-positive early breast cancer with residual invasive disease [1][2][7] - This marks the tenth Breakthrough Therapy designation for Enhertu, highlighting its potential to transform breast cancer treatment [2] - The designation is based on phase III DESTINY-Breast05 data, which indicates Enhertu may reduce invasive disease recurrence compared to current standard care [3] AstraZeneca's Stock Performance - AstraZeneca's shares have increased by 29.3% over the past six months, outperforming the industry average rise of 26.2% [4] Enhertu's Current Approvals and Developments - Enhertu is approved in over 85 countries for second-line treatment of HER2-positive breast cancer and has additional approvals for lung and gastric cancers [8] - Recently, the FDA approved Enhertu in combination with Roche's Perjeta as a first-line treatment for unresectable or metastatic HER2-positive breast cancer based on phase III DESTINY-Breast09 data [9] Partnership and Development Strategy - AstraZeneca and Daiichi Sankyo are jointly responsible for developing and marketing Enhertu globally, except in Japan where Daiichi has exclusive rights [11] - Both companies are pursuing extensive development programs for Enhertu and Datroway across multiple tumor types [11] Recent Study Outcomes - AstraZeneca's phase III LATIFY study, evaluating ceralasertib with Imfinzi in lung cancer, did not meet its primary overall survival goal [12] - The LATIFY study focused on patients without actionable genomic alterations whose disease progressed after prior treatments [13] Imfinzi Sales Performance - Imfinzi generated $4.32 billion in sales during the first nine months of 2025, reflecting a 25% increase driven by demand in lung and liver cancer indications [14]