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On July 26, 2021, Aadi Bioscience announced that the U.
Fyarro has previously been granted Orphan Drug Designation, Fast Track Designation and Breakthrough Therapy Designation by the FDA
PEComa is an ultra-rare subtype of soft tissue sarcoma driven by mTOR activation.
mTOR is a type of serine/threonine kinase.
▲Fyarro is an anti-cancer therapy targeting the mTOR pathway (picture source: Aadi Bioscience's official website)
Fyarro is a nanoparticle albumin inhibitor injection suspension that targets the mTOR pathway
The submission of this new drug application is based on the positive data obtained from the drug in the AMPECT registration trial
▲Efficacy data of the AMPECT registered trial (picture source: Aadi Bioscience's official website)
Note: The original text has been deleted
Reference materials:
[1] Aadi Bioscience Announces FDA Acceptance and Priority Review for the New Drug Application of Fyarro™ for the Treatment of Advanced Malignant PEComa.