Posted by Michael Wonder on 25 Jun 2020
Aadi Bioscience initiates rolling submission of NDA to FDA for nab-sirolimus (ABI-009, Fyarro) for the treatment of advanced malignant PEComa
25 June 2020 - Long-term follow-up data released at ASCO 2020 for AMPECT study.
Aadi Bioscience today announced that the company has initiated submission of a rolling new drug application to the U.S. FDA for the treatment of advanced (metastatic or locally advanced) malignant PEComa (perivascular epithelioid-cell tumour) – a rare form of sarcoma driven by mTOR activation for which there is currently no approved therapy.
The company expects to complete the submission in the 4th quarter of 2020.
