Kazia Therapeutics to Seek FDA Type C Meeting on Overall Survival Data in Glioblastoma and Potential NDA Filing Under Project FrontRunner
Tuesday, October 28, 2025
Kazia Therapeutics Limited has announced plans to request a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss overall survival (OS) results in newly diagnosed glioblastoma (GBM) patients treated with paxalisib. The company aims to obtain regulatory feedback on a possible approval pathway aligned with the FDA Oncology Center of Excellence’s Project FrontRunner initiative.
Paxalisib, an investigational therapy, has shown improved survival outcomes in GBM patients. In a prespecified secondary analysis of newly diagnosed unmethylated GBM patients, the median overall survival was 15.54 months in the paxalisib arm compared to 11.89 months for the concurrent standard of care group.
Kazia intends to present these survival results, along with supporting clinical safety data and the design of a planned confirmatory Phase 3 trial, during the meeting. The company plans to propose initiating the post-approval, randomised Phase 3 study before submitting a New Drug Application (NDA). This approach reflects the FDA’s renewed emphasis on overall survival as the most meaningful endpoint in oncology.
The FDA’s draft guidance identifies overall survival as the “gold standard” endpoint for cancer trials, particularly in conditions such as GBM, where disease progression is rapid and survival outcomes can be reliably assessed.
Project FrontRunner is an FDA initiative that encourages drug developers to explore approval for cancer treatments in earlier clinical settings, rather than limiting development to patients who have exhausted existing options. Kazia’s strategy aligns with this framework, focusing on the potential for conditional approval of paxalisib as a first-line treatment for GBM.
The company noted that several leading oncology developers have referenced Project FrontRunner in recent regulatory filings, highlighting its increasing importance in advancing cancer therapies for earlier treatment settings.
Source: prnewswire.com
