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

Key Takeaways FDA grants Enhertu a Breakthrough Therapy designation for early HER2-positive breast cancer.AZN noted the decision was based on DESTINY-Breast05 results showing lower invasive disease recurrence.AZN's phase III LATIFY study with Imfinzi combo missed its primary overall survival goal in lung cancer.AstraZeneca (AZN) and its Japan-based partner Daiichi Sankyo announced that the FDA has granted a Breakthrough Therapy designation (“BTD”) to their blockbuster antibody-drug conjugate (ADC), Enhertu, ...