The FDA approved sirolimus protein-bound particles for injectable suspension (albumin-bound) (Fyarro, Aadi Bioscience) for adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Efficacy was evaluated in the multicenter, single-arm AMPECT trial of 31 patients with locally advanced unresectable or metastatic malignant PEComa (ClinicalTrials.gov Identifier: NCT02494570). In the trial, patients received sirolimus protein-bound particles