Posted by Michael Wonder on 03 Jan 2019
Aadi Bioscience receives breakthrough therapy designation for Tarzifyx (ABI-009) in PEComa indication
3 January 2019 - Aadi Bioscience today announced that its drug Tarzifyx (sirolimus albumin-bound nanoparticles for injectable suspension, ABI-009) has received breakthrough therapy designation status from the FDA for the indication of advanced (metastatic or locally advanced) Malignant PEComa (perivascular epithelioid cell tumour).
The designation was granted based on data provided to the FDA from Aadi’s ongoing phase 2 registration trial (NCT02494570) in advanced malignant PEComa.
In October 2018, Aadi also received fast track designation from the FDA for Tarzifyx for the same indication. Aadi received orphan drug designation for Tarzifyx for the treatment of PEComa in December 2017.
