Kazia Therapeutics to Request FDA Type C Meeting
Kazia Therapeutics Limited announced its intention to request a Type C meeting with the U.S. Food & Drug Administration (FDA) to discuss overall survival data in GBM and potential NDA filing.
The meeting aims to discuss overall survival findings in newly diagnosed glioblastoma (GBM) patients treated with paxalisib and seek agency feedback on a potential regulatory pathway aligned with the FDA Oncology Center of Excellence’s Project FrontRunner initiative.
GBM remains one of the most lethal cancers with limited therapeutic options.
The company seeks to align its regulatory pathway with the FDA initiative Project FrontRunner.
Author summary: Kazia Therapeutics requests FDA meeting.
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