Kazia Therapeutics Announces Granting of Type C Meeting with FDA to Discuss Potential Next Steps for Paxalisib in the Treatment of Newly Diagnosed Glioblastoma Multiforme

Core Viewpoint - Kazia Therapeutics Limited is advancing its investigational drug paxalisib for glioblastoma multiforme (GBM) and is set to meet with the FDA in December 2024 to discuss registration pathways [1][3]. Company Updates - The company announced results from the Phase II/III clinical trial GBM-AGILE, indicating clinically meaningful improvement in overall survival for newly diagnosed unmethylated GBM patients treated with paxalisib [2]. - Kazia has updated its corporate presentation to include preliminary data from the GBM-AGILE trial, which compares paxalisib to standard care for glioblastoma treatment [4]. - The company plans to participate in several medical conferences in Q4 2024, including the Society for Neuro-Oncology Annual Meeting and the San Antonio Breast Cancer Symposium, to engage with stakeholders and discuss investment opportunities [5][6]. Drug Development and Designations - Paxalisib has received orphan drug designation and fast track designation from the FDA for treating glioblastoma in patients with unmethylated MGMT promoter status, following radiation and temozolomide therapy [3][8]. - The drug has been involved in ten clinical trials since its licensing from Genentech in late 2016, with ongoing studies in various brain cancer types [7][8]. Future Plans - Full data from the GBM-AGILE study, including secondary endpoints, is expected to be presented at a scientific meeting later in 2024 [2]. - Kazia is also developing EVT801, a small-molecule inhibitor of VEGFR3, with promising preclinical data indicating activity against a broad range of tumor types [8].