AADI - Aadi Bioscience wins FDA approval for rare cancer therapy

Aadi Bioscience (NASDAQ:AADI) is trading ~48.3% higher in the pre-market after announcing the FDA approval of FYARRO as an intravenous treatment for adults with an ultra-rare form of cancer called PEComa. The FDA decision allows the use of FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa). According to the company, FYARRO, an inhibitor of mTOR pathway genes, is the first and only FDA-approved therapy for adults with advanced malignant PEComa. The commercial launch of the drug is planned for Q1 2022. In October, Aadi (AADI) announced the publication of data from the registrational AMPECT study for FYARRO in PEComa in the Journal of Clinical Oncology. The results indicated a 39% of overall response rate among 31 evaluable patients.

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Aadi Bioscience wins FDA approval for rare cancer therapy