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