The FDA granted fast track designation to ARX788 as monotherapy for certain patients with HER2-positive breast cancer.
The designation applies to use of the agent for patients with advanced or metastatic disease who received at least one prior anti-HER2-based regimen in the metastatic setting.
ARX788 (Ambrx) — an antibody-drug conjugate that targets the HER2 receptor — consists of two cytotoxic payloads conjugated to a trastuzumab (Herceptin, Genentech)-based antibody.
“This is an important milestone for ARX788 that underscores the strong unmet medical need to develop new and effective treatment options for [patients with breast cancer] whose tumors progressed on currently approved HER2-directed regimens,” Joy Yan, MD, PhD, chief medical officer of Ambrx, said in a company-issued press release. “It’s our mission to drive science forward to help bring innovative therapeutic options to [patients with cancer] and we look forward to working closely with the FDA to optimize and expedite the development of ARX788.” This designation was granted based on the phase 1 studies that assessed the safety, tolerability, pharmacokinetic (PK) and preliminary efficacy of ARX788.
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