Emerging Mini-Protein Radioconjugate Gets FDA Fast Track Designation for Advanced and Metastatic Urothelial Cancer
The AKY-1189 agent was designed for targeting of positive Nectin-4 expressing tumors that reportedly occur in 80 to 90 percent of patients with urothelial cancer.
The Food and Drug Administration (FDA) has issued a fast track designation for the nectin-4 targeting mini-protein radioconjugate AKY-1189 for adults who have progressed to locally advanced or metastatic urothelial cancer (mUC) during or after the use of systemic treatment.
Noting that between 80 to 90 percent of patients with urothelial cancer have positive Nectin-4 expressing tumors, Aktis Oncology, the developer of
“Patients with locally advanced or metastatic urothelial cancer who progress on systemic therapies, such as PADCEV, have limited treatment options,” said Akos Czibere, M.D., Ph.D., the chief medical officer of Aktis Oncology. “The granting of fast track designation affords us a unique opportunity to work closely with the FDA to potentially expedite the development and review process of AKY-1189 with the goal of addressing this unmet medical need by bringing a new therapeutic option to patients with locally advanced or metastatic urothelial cancer.”
The AKY-1189 agent is currently being evaluated in a multisite phase 1b trial for treating locally advanced or mUC as well as other cancers including breast cancer, cervical cancer and non-small cell lung cancer, according to Aktis Oncology.
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