Kazia Therapeutics Product Paxalisib Beats Temozolomide in Overall Survival in Mid-Phase Trial

The US FDA Awards Fast Track Designation to Paxalisib for Glioblastoma 

Kazia Therapeutics Ltd (KZIA) – an Australian oncology biotechnology company, announced that the United States FDA has granted Fast Track Designation (FTD) to Kazia’s paxalisib for glioblastoma, the most aggressive primary brain cancer. The FTD has been granted for the treatment of newly diagnosed glioblastoma with unmethylated O6-Methylguaninemethyl transferase (MGMT) promotor status who have completed initial radiation with temozolomide.

The indication reflects the patient population studied in an ongoing phase II study and is the primary proposed population for the GBM AGILE pivotal study as well as being the intended indication at commercial launch.

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