Posted by Michael Wonder on 06 Jul 2023
Kazia's paxalisib receives fast track designation from FDA for treatment of solid tumour brain metastases harbouring PI3K pathway mutations in combination with radiation therapy
6 July 2023 - Kazia Therapeutics is pleased to announce that its lead program, paxalisib, has been awarded fast track designation by the US FDA for the treatment of solid tumour brain metastases harbouring PI3K pathway mutations in combination with radiation therapy.
The FDA's decision to grant fast track designation was based on promising clinical data from an interim analysis of an on-going Phase 1 clinical trial in which patients with brain metastases from a primary tumour are receiving paxalisib in combination with radiotherapy.
