Aadi Bioscience Shares Rally On FDA Approval For Its First Product For Rare Form Cancer


The FDA has approved Aadi Bioscience Inc's AADI Fyarro (sirolimus protein-bound particles for injectable suspension) (albumin-bound) for perivascular epithelioid cell tumor (PEComa).

  • The approval marks the first and only therapy for adult patients for locally advanced unresectable or metastatic malignant PEComa.
  • PEComa is a family of rare tumors that form in the soft tissues of the stomach, intestines, lungs, female reproductive organs, and genitourinary organs.
  • In Phase 2 registrational AMPECT trial, the overall response rate was 39% (12/31), with two patients achieving a Complete Response after prolonged follow-up. 
  • The median duration of response has not been reached, with a median follow-up of 36 months. 
  • Among responders, 92% had a response lasting greater than or equal to 6 months; 67% had a response lasting up to 12 months, and 58% had a response lasting up to 2 years. 
  • Related content: Benzinga's Full FDA Calendar.
  • Price Action: AADI shares are up 42.6% at $36.39 during the premarket session on the last check Tuesday.
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