FDAnews
www.fdanews.com/articles/209577-ayala-pharmaceuticals-received-fast-track-status-for-al102

Ayala Pharmaceuticals Received Fast Track Status for AL102

September 28, 2022

Ayala Pharmaceuticals’ AL102 has gained Fast Track designation for the treatment of progressing desmoid tumors, which don’t metastasize but often aggressively infiltrate neurovascular structures and vital organs.

AL102 is an oral gamma-secretase inhibitor, part of a drug class that was initially studied in Alzheimer’s disease and then as anticancer agents.

The investigational treatment is being studied in a phase 2/3 clinical trial. The phase 2 portion of the study showed drug efficacy and early tumor responses that deepened over time.

The phase 3 portion of the clinical trial is now enrolling patients in an open label extension study.

View today's stories