Shots:

• The approval is based on the P-II (AMPECT) trial to evaluate the efficacy of Fyarro (IV) in 34 adults aged ≥18yrs. with LA unresectable or metastatic malignant PEComa
• The results showed ORR (39%) as assessed by independent review & 2 patients achieved a CR after prolonged follow up; m-DoR has not been reached with a median follow-up of 36 mos., 92% & 67% had a response through ≥6 & ≥12mos. & 58% had a response through ≥2yrs.
• Fyarro is an mTOR inhibitor & the 1st approved therapy indicated for advanced malignant in adults. The company plans to launch Fyarro in Q1’22

Ref: Aadi Bioscience | Image: Aadi Bioscience