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FDA Grants ARX788 Fast Track Designation for HER2-positive Metastatic Breast Cancer

January 4, 2021

Via: BioSpace

Ambrx announced that the U.S. Food and Drug Administration (FDA) granted ARX788 Fast Track Designation as monotherapy for the treatment of advanced or metastatic HER2-positive breast cancer patients who have received one or more prior anti-HER2 based regimens 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 Joy Yan, MD, PhD, Ambrx Chief Medical Officer. “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.”

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