Kazia faces FDA setback, targets Phase III trial

2 January 2025

Kazia Therapeutics (Nasdaq: KZIA), an oncology-focused Australian drug developer, has been advised by the US Food and Drug Administration that accelerated approval for its brain cancer drug, paxalisib, is unlikely.

The FDA indicated that the overall survival data from the Phase II/III GBM-AGILE study, which demonstrated a 3.8-month OS improvement in glioblastoma patients compared to the standard of care, do not meet the criteria for an accelerated nod.

The disappointing news follows a Type C meeting with the agency regarding the drug's potential as a first-line therapy. However, the agency acknowledged the data as informative for pursuing traditional approval, requiring a registrational Phase III trial.

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