By: IPP Bureau
Last updated : February 24, 2022 7:58 am
Fyarro added to NCCN guidelines as the only preferred mTOR inhibitor to treat malignant PEComa
Aadi Bioscience 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.
Brendan Delaney, Chief Operating Officer of Aadi Bioscience, commented, “We have built a highly experienced commercial team and we are excited to launch Aadi’s first product in the United States. We are committed to working with payers and healthcare providers across the country to help ensure access to Fyarro. We are also pleased that the NCCNSarcoma panel quickly included Fyarro as the only preferred regimen for malignant PEComa. This recommendation will help oncologists to make informed treatment decisions and will also accelerate patient access to therapy across the United States.”