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