Ayala Pharmaceuticals Announces Fast Track Designation Granted by US FDA for AL102 in Progressing Desmoid Tumors
Wednesday, September 28, 2022
Ayala Pharmaceuticals, Inc., a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for rare tumors and aggressive cancers, has announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for AL102, an oral gamma-secretase inhibitor, for the treatment of progressing desmoid tumors. The Fast Track designation is intended to expedite the development and review process of therapies addressing unmet medical needs. Ayala Pharmaceuticals is encouraged by the emerging clinical data supporting AL102 and believes it has the potential to make a meaningful impact on patients' lives. AL102 is currently being evaluated in the RINGSIDE pivotal Phase 2/3 clinical trial for desmoid tumors, with positive interim results from the Phase 2 segment demonstrating efficacy and tolerability. The company has initiated the Phase 3 part of the trial and is also enrolling patients in an open-label extension study.
