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# Aadi Bioscience NDA for Fyarro Approved
- URL: https://www.fdaweb.com/aadi-bioscience-nda-for-fyarro-approved/
- Published: 2021-11-24T12:00:00.000Z
- Updated: 2026-09-14T17:23:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150648

FDA has approved an Aadi Bioscience NDA for Fyarro (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for treating adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). Approval was based on efficacy data from the AMPECT multicenter, single-arm clinical trial in 31 patients with locally advanced unresectable or metastatic malignant PEComa, according to an [FDA release](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sirolimus-protein-bound-particles-malignant-perivascular-epithelioid-cell-tumor?ref=fdaweb.com). The objective response rate was 39%, which included two patients with complete responses, it says. Median duration of response was not reached. And, it says that among responders, 67% had a response lasting greater than 12 months and 58% had a response lasting greater than 24 months.

On the safety side, FDA says the most common (greater than 30% reporting) adverse reactions were stomatitis, fatigue, rash, infection, nausea, edema, diarrhea, musculoskeletal pain, decreased weight, decreased appetite, cough, vomiting, and dysgeusia. The most common Grade 3 to 4 laboratory abnormalities were decreased lymphocytes, increased glucose, decreased potassium, decreased phosphate, decreased hemoglobin, and increased lipase.