{"entity":{"id":"sirolimus-albumin-bound","kind":"drug","name":"Sirolimus protein-bound particles","aka":["nab-sirolimus","ABI-009","Nanoparticle albumin-bound rapamycin"],"tldr":"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.","summary":"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.","status":"approved","asOf":"2026-09-10","wikipedia":"https://en.wikipedia.org/wiki/Sirolimus","links":[{"label":"US label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=sirolimus%20protein-bound"},{"label":"NCI drug page","url":"https://www.cancer.gov/about-cancer/treatment/drugs/sirolimus-protein-bound-particles"}],"tags":["nci-list"],"related":["everolimus","temsirolimus"],"cancers":["sarcoma","pecoma"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["mtor"],"drugs":[],"companies":["aadi-bioscience"],"institutions":[],"pathways":["pi3k-akt-mtor"],"terms":[],"trials":["nct05997017","nct05103358"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Fyarro","modality":"Albumin-bound mTOR inhibitor (intravenous)","mechanism":"Sirolimus bound to albumin nanoparticles; binds FKBP12 and allosterically inhibits mTORC1, the kinase left unrestrained by the TSC1/TSC2 loss that drives PEComa.","approvals":[{"region":"US","year":2021,"indication":"Locally advanced unresectable or metastatic malignant PEComa"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/sirolimus-albumin-bound/","neighbours":{"drug":[{"id":"everolimus","kind":"drug","name":"Everolimus","route":"/drugs/everolimus/"},{"id":"sirolimus","kind":"drug","name":"Sirolimus","route":"/drugs/sirolimus/"},{"id":"temsirolimus","kind":"drug","name":"Temsirolimus","route":"/drugs/temsirolimus/"}],"cancer":[{"id":"epithelioid-haemangioendothelioma","kind":"cancer","name":"Epithelioid haemangioendothelioma","route":"/cancers/epithelioid-haemangioendothelioma/"},{"id":"pecoma","kind":"cancer","name":"Perivascular epithelioid cell tumour (PEComa)","route":"/cancers/pecoma/"},{"id":"sarcoma","kind":"cancer","name":"Sarcomas (soft tissue, bone, GIST)","route":"/cancers/sarcoma/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"mtor","kind":"target","name":"mTOR","route":"/targets/mtor/"},{"id":"tsc1","kind":"target","name":"TSC1","route":"/targets/tsc1/"},{"id":"tsc2","kind":"target","name":"TSC2","route":"/targets/tsc2/"}],"company":[{"id":"aadi-bioscience","kind":"company","name":"Aadi Bioscience","route":"/companies/aadi-bioscience/"}],"pathway":[{"id":"pi3k-akt-mtor","kind":"pathway","name":"PI3K / AKT / mTOR","route":"/pathways/pi3k-akt-mtor/"}],"trial":[{"id":"ampect","kind":"trial","name":"AMPECT","route":"/trials/ampect/"},{"id":"nct04736589","kind":"trial","name":"Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway","route":"/trials/nct04736589/"},{"id":"nct05103358","kind":"trial","name":"Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)","route":"/trials/nct05103358/"},{"id":"nct05997017","kind":"trial","name":"Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer","route":"/trials/nct05997017/"}],"paper":[{"id":"paper-ampect-nab-sirolimus-pecoma-wagner-jco-2021","kind":"paper","name":"AMPECT: nab-sirolimus for malignant perivascular epithelioid cell tumours","route":"/key-papers/paper-ampect-nab-sirolimus-pecoma-wagner-jco-2021/"}]}}