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The U.S. Food and Drug Administration (FDA) has awarded Kazia's Paxalisib treatment for diffuse endogenous bridge glioma (DIPG), a rare and dangerous childhood brain cancer with a mid-life of just one year and a total survival of less than 10% of patients over 2 years, a rare and dangerous childhood brain cancer, The Australian Oncology Biotechnology Corporation announced today.
factors associated with longer survival, including age, symptom incubation period, and ring reinforcement on MRI imaging.
current treatments are radiotherapy (RT) and chemotherapy.
RT as the standard treatment, but only extends the survival time by 3-4 months.
RPDD granted, Kazia is eligible for the Rare Pediatric Disease Priority Examination Certificate (PRV) if Paxalisib is approved for treatment of DIPG.
prV could be sold to other companies for a historical price of between $68 million and $350 million.
Garner, chief executive of Kazia, commented: "Glioblastoma remains a major focus of Paxalisib's research.
there is currently no FDA-approved treatment for patients diagnosed with DIPG, with an average survival of about 9.5 months after diagnosis.
FDA grants RPDD recognition of our efforts and achievements and puts us in a strong position."
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