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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Sarcoma |
| Drug: | Fyarro (nanoparticle albumin-bound rapamycin) (mTORC1 inhibitor) |
| Direction: | Sensitive |
Evidence:
Title:
Aadi Bioscience Announces FDA Acceptance and Priority Review for the New Drug Application of FYARRO™ for the Treatment of Advanced Malignant PEComa
Published date:
07/26/2021
Excerpt:
Aadi Bioscience, Inc. (“Aadi”)...today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for its nanoparticle albumin-bound mTOR inhibitor, FYARRO™ (sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009;) and has granted the company Priority Review status with a Prescription Drug User Fee Act (PDUFA) target action date of November 26, 2021.
