ARX788 on FDA Fast Track for Advanced HER2-positive Breast Cancers

ARX788 on FDA Fast Track for Advanced HER2-positive Breast Cancers
ARX788 has been given a fast track designation by the U.S. Food and Drug Administration as a monotherapy for patients with HER2-positive metastatic breast cancer previously treated with at least one anti-HER2-based regimen. The designation helps to accelerate the clinical development and expedite the approval of promising therapies for serious diseases, by providing more frequent meetings with the FDA and discussions about therapy development. "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," Joy Yan, MD, PhD, chief medical officer of Ambrx, said in a press release. In some breast cancers, abnormal activity of the protein HER2 helps to drive cancer growth, and these cancers are referred to as HER2-positive. These tumors often develop resistance to standard therapies and, as such, need better treatment strategies. Because HER2 drives cancer growth in these tumors, blocking the activity of this protein can limit cancer growth and even kill cancer cells. ARX788, developed by Ambrx, is an investigational antibody-drug conjugate (ADC) that combines the HER2-targeting antibody trastuzumab (marketed as Herceptin, among others) with two toxic payloads of amberstatin269, also known as AS269, a potent cytotoxic tubulin inhibitor. Tubulin is a major component of microtubules, which are necessary for the division of cells. Targeting tubulin disrupts the assembly of the microtubules in fast-dividing tumor cells, making them more prone to cell death. The FDA’s decision was based on data from Phase 1 studies which evaluated the safety, tolerability, pharmacokinetic, and efficacy of A
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