Kazia Therapeutics continues strong month with more good news from US health regulators
Health & Biotech
Health & Biotech
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Cancer-fighting biotech Kazia Therapeutics (ASX:KZA) has received another approval from US health authorities, as it continues with phase II clinical trials for its brain cancer treatment.
The company announced its paxalisib treatment has been awarded a Fast Track Designation (FTD) by the US Food & Drug Administration (FDA).
Paxalisib is used in the fight against glioblastoma, which is the most common and aggressive form of brain cancer.
KZA shares jumped by another 35 per cent, two weeks after gaining more than 50 per cent when the company announced paxalisib had been awarded a Rare Pediatric Disease Designation for the treatment of childhood brain cancer.
Kazia CEO Dr James Garner said the FTD was an important step for the company as it moved towards the submission of a New Drug Application (NDA) next year.
Having an FTD helps to expedite the development process by giving companies an improved platform to work with health regulators, such as access for face-to-face meetings and written submissions.
When Kazia gets around to its NDA, it will also be eligible for accelerated approval and priority review from the FDA, which can also speed up the approval process.
Garner also highlighted the benefits of being eligible for a “rolling review” process, where Kazia could present sections of the paxalisib NDA as they became available, rather than being required to present the whole thing at once.
The company is currently undertaking phase II clinical trials for the treatment.
Interim data presented to US health authorities in June showed survival rates among patients provided with the treatment was calculated at 17.7 months, “which compares favourably to an historical figure of 12.7 months for temozolomide, the existing FDA-approved standard of care”, Kazia said.