Aktis Oncology's AKY-1189 Receives FDA Fast Track Designation
Aktis Oncology announced that the U.S. Food and Drug Administration, FDA, has granted Fast Track designation to AKY-1189 for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have progressed on or after prior systemic therapies. Generated using Aktis' miniprotein radioconjugate platform, AKY-1189 is designed to deliver actinium-225, a highly potent alpha-emitting radioisotope, to Nectin-4 expressing tumors. Approximately 80 - 90% of urothelial cancer patients show positive expression of Nectin-4.