Kazia Therapeutics, an Australian oncology company, has secured fast track designation (FTD) from the US Food and Drug Administration (FDA) for paxalisib (formerly GDC-0084) for the treatment of glioblastoma.
The specific indication for which the designation has been granted is for newly diagnosed glioblastoma patients with unmethylated O6-Methylguaninemethyltransferase (MGMT) promotor status who had initial radiation with concomitant temozolomide.
According to Kazia Therapeutics, it is evaluating paxalisib in the same patient population in an ongoing phase 2 trial. The same patient group is also the primary proposed population for the GBM AGILE pivotal trial and is the planned indication at commercial launch.
Glioblastoma is considered as the most common and most aggressive type of primary brain cancer.
Dr James Garner – Kazia Therapeutics CEO said: “In awarding Fast Track Designation to paxalisib, FDA has recognised the drug’s potential to meaningfully improve outcomes for patients with glioblastoma. This is a very powerful acknowledgement.
“The opportunities that Fast Track Designation creates, as we move towards an NDA filing, are of great value and have the potential to substantially accelerate the commercialisation of paxalisib. In particular, the ‘rolling review’ process enables Kazia to complete and submit substantial sections of our NDA filing in advance, saving time and reducing risk for the product.
“We look forward to working closely with FDA as we move into the final stage of development for paxalisib.”
Earlier this month, Kazia Therapeutics was granted the rare pediatric disease designation (RPDD) for paxalisib from the FDA for the treatment of diffuse intrinsic pontine glioma (DIPG), a type of childhood brain cancer.