Kazia Therapeutics Ltd (ASX:KZA) (NASDAQ:KZIA) soared almost 50% on being awarded US Food and Drug Administration (FDA) Fast Track Designation (FTD) to paxalisib for the treatment of glioblastoma – the most common and aggressive form of primary brain cancer.
FTD is designed to expedite development of pharmaceutical products which demonstrate the potential to address unmet medical needs in serious or life-threatening conditions.
It provides Kazia with enhanced access to FDA, including opportunities for face-to-face meetings and written consultation throughout the remaining development of paxalisib.
Shares jumped almost 50% today to A$1.235, a new four-year high for the innovative oncology-focused biotechnology company, before finishing the day up 35% at $1.12 on volume of almost 5 million.
Chief executive officer James Garner 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.
“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.”
Drugs with FTD are eligible to apply for Accelerated Approval and Priority Review at the time of a New Drug Application (NDA) submission, which may result in faster product approval.
FTD also allows for ‘rolling review’, whereby Kazia may submit completed sections of the paxalisib NDA as they become available, rather than at the end of development.
Kazia completed recruitment to its phase II clinical trial of paxalisib in newly diagnosed glioblastoma in February 2020, and interim clinical data was presented at the American Association of Cancer Research (AACR) Virtual Annual Meeting II in June 2020.
Overall survival was calculated at 17.7 months, which compares favourably to a historical figure of 12.7 months for temozolomide, the existing FDA-approved standard of care.
Kazia expects to present further data from this study in the later in the year before concluding the study in early 2021.
Paxalisib has been selected to join the international GBM AGILE pivotal study in glioblastoma and recruitment is expected to begin later in the year.