Novartis today announced that the U.S.Food and Drug Administration (FDA) approved Lutathera® (USAN: lutetium Lu 177 dotatate / INN: lutetium (177Lu) oxodotreotide) for the treatment of pediatric patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut NETs.

诺华今天宣布，美国食品和药物管理局（FDA）批准Lutathera®（USAN：lutetium Lu 177 dotatate/INN：lutetium（177Lu）oxodotreotide）用于治疗12岁及以上生长抑素受体阳性（SSTR+）胃肠胰神经内分泌肿瘤（GEP-NETs）的儿科患者，包括前肠，中肠和后肠NETs。

This approval makes Lutathera the first therapy specifically reviewed and approved for use in pediatric patients with GEP-NETs. “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,” said Tina Deignan, Therapeutic Area Head, Oncology US.

这一批准使Lutathera成为第一个专门审查和批准用于GEP NETs儿科患者的疗法。美国肿瘤学治疗领域负责人蒂娜·德伊南（TinaDeignan）说：“卢塔瑟拉（Lutathera）现在是第一个专门针对GEP-NETs儿童的疗法，为患有这种罕见癌症的年轻患者提供了新的希望。”。

“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.” NETs are a type of cancer that originates in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies1.

“放射性配体疗法在塑造癌症治疗的未来方面具有非凡的潜力。通过这一批准，我们朝着实现这一愿景迈出了重要的一步，加强了我们在多种癌症类型和治疗环境中研究和开发RLT平台的承诺。”NETs是一种起源于全身神经内分泌细胞的癌症，通常被认为是生长缓慢的恶性肿瘤1。

The diagnosis of NETs is often delayed due to the inactive nature of the disease, and approxi.

由于疾病的无活性和近似性，NETs的诊断通常会延迟。