AstraZeneca's Enhertu granted FDA breakthrough therapy designation

Drugmaker AstraZeneca's Enhertu candidate has been granted breakthrough therapy designation in the US for adult patients with HER2-low metastatic breast cancer.

AstraZeneca said on Wednesday that following results from its DESTINY-Breast04 trial on Enhertu, which was jointly developed with Japanese pharmaceutical company Daiichi Sankyo, the drug had demonstrated a "significant improvement" in both progression-free survival and overall survival.

The Food and Drug Administration's breakthrough therapy designation was designed to accelerate the development and regulatory review of potential new medicines intended to treat a serious condition and address "a significant unmet medical need". The new medicine also needs to have shown encouraging preliminary clinical results that demonstrate "substantial improvement" on a "clinically significant" endpoint over available medicines.

Susan Galbraith, executive vice president of oncology R&D at AstraZeneca, said: "Today's news is a significant validation of the potential we see for the historic DESTINY-Breast04 trial to enable a paradigm shift in how breast cancer is classified by targeting the full spectrum of HER2 expression.

"Enhertu continues to show transformative potential, and this milestone represents an important advance for patients with HER2-low metastatic breast cancer who are in urgent need of new treatment options and better outcomes."

As of 0825 BST, AZN shares were down 0.17% at 10,314.0p.