Kazia Therapeutics’ (NASDAQ:KZIA) paxalisib received FDA fast track designation for the treatment of glioblastoma.
Interim data from the company’s Phase 2 trial demonstrated overall survival of 17.7 months for patients receiving paxalisib, compared with a historical figure of 12.7 months for temozolomide, the current FDA-approved standard-of-care.
Kazia expects to present further data from this study in the second half of 2020, and to conclude the study in early 2021.
“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 commercialization of paxalisib,” James Garner, Kazia’s CEO, said in a statement.
“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,” he added.
Paxalisib was granted FDA orphan designation for glioblastoma in February 2018 and FDA rare pediatric disease designation for the treatment of diffuse intrinsic pontine glioma earlier this month.
