Kazia Therapeutics to Meet with FDA on Paxalisib's Glioblastoma Registration Pathway
Key Insights
Kazia Therapeutics (search) will meet with the FDA in December 2024 to discuss potential registration pathways for paxalisib in newly diagnosed glioblastoma (search) (GBM (search)).
The discussion follows Phase II/III GBM (search)-AGILE trial results showing clinically meaningful overall survival improvement in newly diagnosed, unmethylated GBM patients treated with paxalisib.
Paxalisib has received orphan drug and fast track designations from the FDA for glioblastoma (search) patients with unmethylated MGMT promoter status after initial therapy.
Kazia Therapeutics (search) is set to meet with the U.S. Food and Drug Administration (FDA) in December 2024 to discuss potential pathways for the registration of paxalisib, a PI3K/mTOR (search) inhibitor, for treating newly diagnosed glioblastoma multiforme (search) (GBM (search)). This Type C meeting follows encouraging results from the Phase II/III GBM-AGILE study.
GBM-AGILE Trial Results
In July 2024, Kazia announced findings from the GBM (search)-AGILE trial, a Phase II/III study. The results indicated that newly diagnosed, unmethylated GBM patients treated with paxalisib demonstrated a clinically meaningful improvement in overall survival in a pre-specified secondary analysis. The full data, including secondary endpoints, from the paxalisib arm of the GBM-AGILE study are expected to be presented at an upcoming scientific meeting.
Regulatory Designations
Paxalisib has already been granted orphan drug designation and fast track designation by the FDA for glioblastoma (search) in patients with unmethylated MGMT promoter status, specifically following radiation plus temozolomide therapy. These designations are intended to expedite the development and review of drugs for serious conditions.
Corporate Presentation and Conference Participation
Kazia Therapeutics (search) has updated its corporate presentation to include preliminary data from the GBM (search) AGILE Phase II/III clinical trial, which evaluated paxalisib against the standard of care for glioblastoma (search). The updated presentation is available on the company's website.
Kazia plans to participate in several medical conferences in the fourth quarter of 2024, including the Society for Neuro-Oncology 29th Annual Meeting and Education Day in November and the San Antonio Breast Cancer Symposium in December. These events will provide opportunities to engage with key stakeholders and share the company's vision for developing innovative cancer treatments.