Marengo Wins Second FDA Fast Track for Invikafusp Alfa
Cambridge, Mass. – October 15, 2026 -- The U.S. Food and Drug Administration has granted a second Fast Track Designation to Marengo Therapeutics' invikafusp alfa, extending the drug's expedited status from one tumor type to all tumor mutational burden high (TMB-H) solid tumors regardless of tissue of origin.
The new designation covers unresectable, locally advanced or metastatic TMB-H solid tumors that have progressed after prior treatment, including immune checkpoint inhibition, and for which no satisfactory treatment options exist. Marengo believes invikafusp alfa is the first immuno-oncology T-cell agonist to receive Fast Track Designation in a biomarker-defined, tissue-agnostic indication.