Aadi Bioscience receives FDA approval for FYARRO in advanced malignant PEComa

Whitehawk Therapeutics, Inc.

FDA approved FYARRO (sirolimus protein-bound particles) for adult patients with advanced unresectable or metastatic malignant PEComa.
FYARRO is the first and only FDA-approved treatment for advanced malignant PEComa, an ultra-rare sarcoma.
In pivotal AMPECT trial, overall response rate was 39% (12/31); median duration of response not reached after median 36-month follow-up.
Launch planned for Q1 2022; investor conference call scheduled for today at 8:30 am ET.

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