Kazia Therapeutics (NASDAQ:KZIA) has announced that the FDA has granted a Type C meeting scheduled for December 2024 to discuss potential pathways for the registration of the company’s blood-brain barrier-penetrant PI3K/mTOR inhibitor, paxalisib, for the treatment of patients with newly diagnosed glioblastoma multiforme (GBM).
Previously, the FDA granted Paxalisib orphan drug designation and fast track designation for glioblastoma in patients with unmethylated MGMT promoter status, following radiation plus temozolomide therapy.
In July 2024, the company announced results from the Phase II/III clinical trial, GBM-AGILE, in which newly diagnosed unmethylated patients with glioblastoma treated with paxalisib showed clinically meaningful improvement in a prespecified secondary analysis for overall survival. Full data, including secondary endpoints from the paxalisib arm of the GBM-AGILE study, is expected to be presented at a scientific meeting later this year.
