The FDA has granted Fast Track designation to Ayala Pharmaceuticals’ AL101 for the treatment of recurrent or metastatic adenoid cystic carcinoma (ACC). AL101 is a potent, selective, injectable small molecule gamma secretase inhibitor and was granted Orphan Drug designation in May 2019 for the treatment of ACC.1

“Receiving Fast Track designation from the FDA underscores the urgent need for a targeted therapy to address the devastating nature of ACC, a rare disease for which no standard drug therapy currently exists,” said Roni Mamluk, PhD, chief executive officer of Ayala, in a press release.1

Ayala is currently evaluating AL101 in the ongoing phase 2 ACCURACY trial for the treatment of patients with recurrent/metastatic adenoid cystic carcinoma. The company also is planning to hold phase 2 trials of AL101 for the treatment of recurrent/metastatic triple negative breast cancer, and relapsed/refractory T-cell acute lymphoblastic leukemia.2

The FDA’s Fast Track program is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening disease or conditions and demonstrate the potential to address unmet medical needs. The designation offers the opportunity for more frequent interactions with the FDA over the course of drug development and allows for rolling review of a New Drug Application if relevant criteria are met.1

  1. Ayala Pharmaceuticals Granted U.S. FDA Fast Track Designation for AL101 for the Treatment of Recurrent or Metastatic Adenoid Cystic Carcinoma [news release]. Rehovot, Israel and Wilmington, DE; March 03, 2020 : Ayala Pharmaceuticals website. Accessed March 3, 2020.
  2. AL101 Clinical Trial. Ayala website. Accessed March 3, 2020.