On July 26, 2021 Aadi Bioscience, Inc. ("Aadi"), a privately-held, clinical-stage biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for its nanoparticle albumin-bound mTOR inhibitor, FYARRO (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009;) and has granted the company Priority Review status with a Prescription Drug User Fee Act (PDUFA) target action date of November 26, 2021 (Press release, Aadi Bioscience, JUL 26, 2021, View Source [SID1234585170]).
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Priority Review is granted to investigational therapies that, if approved, may offer significant improvements in the treatment, prevention, or diagnosis of a serious condition when compared to standard applications. FYARRO has previously been granted Orphan Drug, Fast Track and Breakthrough Therapy designations.
Neil Desai, Ph.D., Founder, CEO and President of Aadi, stated, "We are very pleased with FDA’s acceptance of our NDA with Priority Review for FYARRO in patients with advanced malignant PEComa, an ultra-rare sarcoma. If approved, FYARRO will be the first FDA-approved therapy for the treatment of patients with this disease. We look forward to working with the FDA during its review and would like to thank the many patients, caregivers and physicians whose contributions have been invaluable and allowed us to develop this important therapy. In parallel, we continue to work on our commercial preparations to ensure a timely launch for the PEComa patient population."
Aadi’s NDA submission is based on data from the AMPECT registration trial evaluating FYARRO as a monotherapy in patients with advanced malignant PEComa. FYARRO achieved a 39% (95% CI: 22%-58%) independently reviewed confirmed overall response rate (ORR) in this patient population. These data were presented at the 2020 ASCO (Free ASCO Whitepaper) meeting.1