AstraZeneca’s and Daiichi Sankyo’s Enhertu Gains Another Breakthrough Therapy Designation

The FDA has granted AstraZeneca’s and Daiichi Sankyo’s antibody drug conjugate Enhertu (trastuzumab deruxtecan) a fifth Breakthrough Therapy designation for patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-low breast cancer who have received certain prior treatments.

The latest designation is for patients who have received a prior systemic therapy or developed disease recurrence within six months of completing adjuvant chemotherapy.

The new designation was supported by results from a phase 3 trial in which patients given Enhertu showed a significant improvement in both progression-free survival and overall survival compared with those given the physician’s choice of chemotherapy.

The FDA first approved Enhertu in 2019 for patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. The potential blockbuster drug has also received FDA’s accelerated approval for the treatment of unresectable or metastatic HER2-positive breast cancer.