Kazia Therapeutics Charts Path Forward for Paxalisib After FDA Feedback

Kazia Therapeutics ( (KZIA) ) has provided an announcement.

Kazia Therapeutics has provided an update on the regulatory pathway for its drug paxalisib following a Type C meeting with the FDA. The FDA indicated that data on overall survival (OS) from the GBM-AGILE study would not support accelerated approval but could aid in traditional approval. Key aspects of a phase 3 study design have been aligned with the FDA, marking a significant step in the drug’s potential approval process for treating glioblastoma. Beyond glioblastoma, paxalisib is being tested in other cancers, and the company plans to outline its strategic path forward by January 2025, aiming to maximize shareholder value.

More about Kazia Therapeutics

Kazia Therapeutics Limited is an oncology-focused drug development company based in Sydney, Australia. Its lead program, paxalisib, is an investigational brain-penetrant inhibitor of the PI3K / Akt / mTOR pathway, being developed to treat various forms of brain cancer. The company has been involved in multiple clinical trials and holds several designations from the FDA, including Orphan Drug and Fast Track Designations for various applications of paxalisib. In addition, Kazia is developing EVT801, a small-molecule inhibitor of VEGFR3, targeting a broad range of tumor types.

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