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Aadi Bioscience Announces U.S. Commercial Launch and Availability of FYARRO™ for the Treatment of Adult Patients with Locally Advanced Unresectable or Metastatic Malignant PEComa
– FYARRO™ added to NCCN® Guidelines as the only preferred mTOR inhibitor to treat malignant PEComa –– PRECISION-1 tumor agnostic study for TSC1 or TSC2
About this update from Whitehawk Therapeutics, Inc.
[{"type":"text","content":"– FYARRO™ added to NCCN® Guidelines as the only preferred mTOR inhibitor to treat malignant PEComa –– PRECISION-1 tumor agnostic study for TSC1 or TSC2 alterations is open for enrollment – LOS ANGELES, Feb. 23, 2022 (GLOBE NEWSWIRE) -- Aadi Bioscience, Inc. (“Aadi”) (Nasdaq: AADI), a biopharmaceutical company focusing on precision therapies for genetically-defined cancers with alterations in mTOR pathway genes, today announced the launch and commercial availability of its first proprietary product, FYARRO™ (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for intravenous use for the treatment of adult patients with locally advanced unresectable or metastatic malignant PEComa. FYARRO was approved by the U.S. Food and Drug Administration (FDA) on November 22, 2021 and is the first treatment specific to this ultra-rare sarcoma. FYARRO was also recently added to the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN® Guidelines) as the only preferred treatment regimen for malignant PEComa. “All of us at Aadi are truly proud to be able to offer this treatment to patients living with malignant PEComa, who have had no FDA-approved treatment options specific to this ultra-rare cancer until now. We are thankful to all the patients, families, and caregivers whose participation in and support of the AMPECT trial ultimately made this advancement possible,” commented Neil Desai, Ph.D., Founder, President and Chief Executive Officer of Aadi. “We consider the availability of FYARRO in this indication an important advancement towards building out a potential ‘pipeline within a product’ and look forward to studying FYARRO in other tumor types with alterations in mTOR pathway genes. Our PRECISION-1 study, a registrational trial of FYARRO in patients with solid tumors with pathogenic alterations in TSC1 or TSC2 genes, is now open for enrollment,” he added. Aadi has also launched “Aadi Assist” as its comprehensive patient support program. This program offers resources designed to connect patients with co-pay assistance, referrals, educational resources, verification of benefits and to ensure access to this important drug as quickly and efficiently as possible. Brendan Delaney, Chief Operating Officer of Aadi Bioscience, commented, “We have built a highly experienced commercial team and ...