Terremoto Biosciences Granted FDA Fast Track Designation for TER-2013, an AKT1-Selective Small Molecule Inhibitor for Breast Cancer
Fast Track Designation granted for TER-2013 in HR+/HER2- breast cancer with AKT/PI3K/PTEN-alterations following endocrine therapy and CDK4/6 inhibitor therapy
Terremoto Biosciences, a biotechnology company developing highly targeted, small molecule medicines, today announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation for TER-2013, the Company’s lead AKT1-selective inhibitor, in patients with locally advanced, unresectable or metastatic HR+/HER2- breast cancer harboring one or more AKT/PI3K/PTEN alterations following progression on at least one endocrine-based therapy and CDK4/6 inhibitor for advanced disease.
Fast Track Designation is intended to facilitate the development and expedite the review of therapies for serious conditions with unmet medical need. The designation allows for more frequent interactions with the FDA regarding development plan, clinical trial design and data requirements to support potential approval. If relevant criteria are met, programs with Fast Track designation are eligible for accelerated approval and priority review.
