Posted by Michael Wonder on 03 Mar 2020
Ayala Pharmaceuticals granted U.S. FDA fast track designation for AL101 for the treatment of recurrent or metastatic adenoid cystic carcinoma
3 March 2020 - Ayala Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to AL101 for the treatment of recurrent or metastatic adenoid cystic carcinoma.
AL101, Ayala’s lead product candidate, is a potent, selective, injectable small molecule gamma secretase inhibitor and was granted orphan drug designation in May 2019 for the treatment of adenoid cystic carcinoma.
AL101 is an investigational small molecule GSI that is designed to potently and selectively inhibit Notch 1, 2, 3 and 4, and is currently being evaluated in the Phase 2 ACCURACY trial in patients with adenoid cystic carcinoma.
