Skip to main content

Fyarro FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 24, 2021.

FDA Approved: Yes (First approved November 22, 2021)
Brand name: Fyarro
Generic name: sirolimus protein-bound
Dosage form: Lyophilized Powder for Injectable Suspension
Company: Aadi Bioscience, Inc.
Treatment for: Malignant Perivascular Epithelioid Cell Tumor (PEComa)

Fyarro (sirolimus protein-bound particles) is an inhibitor of mechanistic target of rapamycin kinase (mTOR) for the treatment of malignant perivascular epithelioid cell tumor (PEComa).

  • Malignant PEComa is a rare and aggressive form of soft-tissue sarcoma. Malignant PEComas have been shown to frequently harbor mutations in the TSC1 and/or TSC2 genes that result in the activation of mTOR pathway. In tumor cells, abnormally activated mTOR sends signals that encourage tumor cells to grow, metastasize, and invade new healthy tissues.
  • Sirolimus works to slow tumor growth by inhibiting mTOR. The sirolimus in Fyarro bound to human albumin to enhance the delivery of the drug into tumor cells.
  • Fyarro is administered as an IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity.
  • Fyarro may cause serious adverse reactions including stomatitis, myelosuppression, infections, hypokalemia and hyperglycemia, ILD/non-infectious pneumonitis, hemorrhage, and hypersensitivity reactions.
  • Common adverse reactions include stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, dysgeusia, and laboratory abnormalities.

Development timeline for Fyarro

Nov 23, 2021Approval FDA Approves Fyarro (sirolimus protein-bound particles) for the Treatment of Malignant Perivascular Epithelioid Cell Tumor (PEComa)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.