Ambrx’s Breast Cancer Drug Nabs FDA Fast-Track Designation

The FDA has granted Ambrx’s ARX788 Fast-Track designation for treating advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in patients who have already received one or more previous anti-HER2 lines of therapy.

ARX788 is an antibody drug conjugate that targets HER2, a tyrosine kinase receptor growth-enabling protein located on certain cancer cells that causes aggressive expansion of the disease.

The Fast-Track designation was supported by positive results from phase 1 studies evaluating the drug for safety, tolerability, pharmacokinetic profile and preliminary efficacy.