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Treats locally advanced unresectable or metastatic malignant … cell tumor (PEComa). NDA 213312, held by Aadi. Sirolimus.
As of Nov 13, 2026, NDA 213312 (Fyarro), held by Aadi, was first approved by FDA on Nov 22, 2021, with 1 approved supplement and 0 published complete response letters.
First approved: Nov 22, 2021
Review: Priority
Supplements approved: 1
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
FYARRO is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa).
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters.Drugs@FDA and FDA complete response letters
