FDA Approves Novartis' Lutathera As First Therapy For Pediatric Patients With Gastroenteropancreatic Neuroendocrine Tumors
Portfolio Pulse from Vandana Singh
The FDA has approved Novartis AG's Lutathera for pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), marking it as the first therapy specifically approved for this demographic. This approval is based on the NETTER-P trial, which showed a safety profile consistent with the adult population. Lutathera is already approved in the US for adults with SSTR-positive GEP-NETs and has approvals in Europe and Japan for similar indications. Following this news, NVS shares rose by 2.29% to $97.30.
April 23, 2024 | 7:05 pm
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POSITIVE IMPACT
Novartis AG's Lutathera receives FDA approval for pediatric GEP-NETs, marking a significant expansion in its treatment indications. This approval could enhance Novartis' market position in oncology, especially in pediatric care.
The FDA approval of Lutathera for pediatric patients expands its market potential and reinforces Novartis' commitment to addressing rare cancers. The positive market reaction, as evidenced by the share price increase, reflects investor confidence in the drug's commercial success and its potential to contribute significantly to Novartis' revenue. The approval also strengthens Novartis' position in the oncology sector, particularly in treatments for neuroendocrine tumors.
CONFIDENCE 90
IMPORTANCE 90
RELEVANCE 100