FDA Fast Track of Novel Agent May Open Doors in Subset of Breast Cancer

January 8, 2021
Ryan McDonald

The FDA’s fast track designation for ARX788 to treat patients with advanced or metastatic HER2-positive breast cancer who have received at least one previous anti-HER2-based treatment in the metastatic setting, may open the doors to an accelerated approval.

The Food and Drug Administration (FDA) has granted a fast track designation to ARX788, an antibody drug conjugate that targets the HER2 receptor, to treat patients with advanced or metastatic HER2-positive breast cancer who have received at least one previous anti-HER2-based treatment in the metastatic setting.

“This is an important milestone for ARX788 that underscores the strong unmet medical need to develop new and effective treatment options for breast cancer patients whose tumors progressed on currently approved HER2 directed regimens,” said Ambrx’s chief medical officer Dr. Joy Yan in a company-issued press release. “It's our mission to drive science forward to help bring innovative therapeutic options to cancer patients and we look forward to working closely with the FDA to optimize and expedite the development of ARX788.”

The agency grants fast track designation “to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need,” according to its website. This designation has the potential to lead to an accelerated approval for a drug.

The agency based its decision on phase 1 studies of the novel therapy that analyzed its safety, tolerability and preliminary efficacy.

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