FDA Approves Novartis' Lutathera As First Therapy For Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors [Yahoo! Finance]
Novartis AG (NVS)
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Source: Yahoo! Finance
patients 12 years and older with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (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. Related: Novartis Stock Gains On European Drugmaker's Q1 Earnings Surprise, Lifts Annual Outlook NETs are a type of cancer that originates in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies1. The diagnosis of NETs is often delayed due to the inactive nature of the disease, and approximately 10% to 20% of pediatric patients are diagnosed with metastatic disease. The approval was based on the NETTER-P trial, which evaluated Lutathera in patients aged 12 to The study reported a safety profile consistent with the adult population studied in NETTER-1, the pivotal trial for approval of Lutathera in adults. In addition, the estimated
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NVS
Earnings
- 4/23/24 - Beat
NVS
Sec Filings
- 4/23/24 - Form 6-K
- 2/15/24 - Form S-8
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