FDA Approves Eflornithine for Adult, Pediatric Patients With ...
FDA approved eflornithine (Iwilfin) to reduce relapse risk in high-risk neuroblastoma patients post-therapy. Based on Study 3b vs. ANBL0032 trial, it showed improved event-free and overall survival. Common side effects include otitis media and diarrhea. Approved after FDA committee's positive vote.
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Neuroblastoma, a prevalent pediatric cancer, has seen improved survival rates with modern therapies. High-risk cases, half of all, undergo intensive treatment including chemotherapy, stem cell transplant, and immunotherapy. FDA recently approved eflornithine to reduce relapse risk in HRNB patients, showing promising efficacy in trials. Future research aims to explore eflornithine's broader applications and long-term effects.
FDA approved eflornithine (Iwilfin) to reduce relapse risk in high-risk neuroblastoma patients post-therapy. Based on Study 3b vs. ANBL0032 trial, it showed improved event-free and overall survival. Common side effects include otitis media and diarrhea. Approved after FDA committee's positive vote.
On December 13, 2023, the FDA approved eflornithine (IWILFIN) to reduce relapse risk in high-risk neuroblastoma patients post-therapy. Approval based on an externally controlled trial showed improved survival rates. Common side effects include hearing loss and otitis media. This marks the first oncology drug approval using ECT for effectiveness evidence.