AstraZeneca's Enhertu to be reviewed by FDA following DESTINY-Lung01 trial

Drugmaker AstraZeneca said on Tuesday that its Enhertu candidate had been granted priority review in the US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer.

AstraZeneca said the US FDA's decision to review Enhertu, a HER2-directed antibody drug conjugate being jointly developed by AZN and Daiichi Sankyo, was based on pivotal DESTINY-Lung01 results showing the frug demonstrated a 54.9% tumour response rate.

The Food and Drug Administration grants priority review to applications for medicines that, if approved, would offer "significant improvements over available options" by demonstrating safety or efficacy improvements, preventing serious conditions, or enhancing patient compliance.

Susan Galbraith, AstraZeneca's executive vice president of oncology R&D, said: "The DESTINY-Lung01 trial confirmed the HER2 mutation as an actionable biomarker in non-small cell lung cancer.

"If approved, Enhertu has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic non-small cell lung cancer who currently have no targeted treatment options."

As of 0805 BST, AstraZeneca shares were down 0.32% at 10,502.0p.