Sirolimus protein-bound particles
Fyarro is an infusion of the transplant drug sirolimus packaged in albumin particles. It is the first approved treatment for malignant PEComa, a rare soft-tissue tumour driven by loss of the TSC genes.
Overview
Sirolimus protein-bound particles were approved by the FDA in November 2021 for adults with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumour (PEComa), on the AMPECT single-arm trial in which 39% of 31 patients responded, with responses concentrated in tumours carrying TSC2 inactivation and several lasting over two years. The albumin formulation allows higher intratumoural drug exposure than oral rapalogues. It is being studied in other TSC1/2-altered solid tumours (PRECISION 1). Stomatitis, myelosuppression, hyperglycaemia, hyperlipidaemia and pneumonitis are the mTOR-class effects.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2021 | Locally advanced unresectable or metastatic malignant PEComa |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery for this drug: (TITLE:"Sirolimus protein-bound particles" OR ABSTRACT:"Sirolimus protein-bound particles" OR TITLE:"Fyarro" OR ABSTRACT:"Fyarro" OR TITLE:"nab-sirolimus" OR ABSTRACT:"nab-sirolimus" OR TITLE:"ABI-009" OR ABSTRACT:"ABI-009" OR TITLE:"Nanoparticle albumin-bound rapamycin" OR ABSTRACT:"Nanoparticle albumin-bound rapamycin") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Sirolimus protein-bound particles, not a curated reading list.
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