Fyarro (sirolimus protein-bound particles [albumin-bound]) has been made available for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), according to Aadi Bioscience.

Fyarro is an mTOR inhibitor bound to human albumin. The approval was based on data from the multicenter phase 2 AMPECT study (ClinicalTrials.gov Identifier: NCT02494570), which evaluated the efficacy of Fyarro in 34 adults aged 18 years and older with locally advanced unresectable or metastatic malignant PEComa. Findings from the trial showed durable responses with Fyarro in mTOR inhibitor-naïve patients.

Fyarro is contraindicated in patients with a history of severe hypersensitivity to sirolimus, other rapamycin derivatives, or albumin. Treatment has also been associated with stomatitis, myelosuppression, infection, hypokalemia, hyperglycemia, interstitial lung disease, hemorrhage, and hypersensitivity reactions.

The most common adverse reactions reported with Fyarro include stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, and dysgeusia. 

Fyarro is supplied as a lyophilized powder containing 100mg of sirolimus formulated as albumin-bound particles in single-dose vial for reconstitution. 

To help patients gain access to treatment, Aadi Bioscience has launched a comprehensive patient support program called Aadi Assist.

Fyarro has also been added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN® Guidelines) as the only preferred treatment regimen for malignant PEComa.


  1. Aadi Bioscience announces US commercial launch and availability of Fyarro™ for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa. News release. Aadi Bioscience. Accessed February 23, 2022. https://www.globenewswire.com/news-release/2022/02/23/2390203/0/en/Aadi-Bioscience-Announces-U-S-Commercial-Launch-and-Availability-of-FYARRO-for-the-Treatment-of-Adult-Patients-with-Locally-Advanced-Unresectable-or-Metastatic-Malignant-PEComa.html
  2. Fyarro. Package insert. Aadi Bioscience; 2022. Accessed February 23, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/213312Orig1s000Corrected_lbl.pdf