Novartis reports FDA approves Lutathera for pediatric GEP-NETs

Novartis announced that the U.S. Food and Drug Administration approved Lutathera radioligand therapy for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, including foregut, midgut, and hindgut NETs. “This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs,” the company stated. “Lutathera is now the very first therapy approved specifically for children with GEP-NETs, offering new hope to young patients living with this rare cancer. Radioligand therapies have extraordinary potential to shape the future of cancer care. With this approval, we have taken another vital step toward fulfilling that vision, strengthening our commitment to researching and developing the RLT platform across multiple cancer types and treatment settings,” added Tina Deignan, Therapeutic Area Head, Oncology US.