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USFDA gives nod to Novartis therapy for rare cancer among children - Pharma News

USFDA gives nod to Novartis therapy for rare cancer among children - Pharma News
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United statesTina deignanTheodore laetschSun pharmaDrug administrationDr reddy labsDevelopmental therapeutics programTherapeutic area head

Novartis Lutathera receives FDA approval to treat neuroendocrine tumours in paediatric patients

Novartis Lutathera receives FDA approval to treat neuroendocrine tumours in paediatric patients
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United statesTina deignanTheodore laetschDrug administrationAmerican society

Lutathera Approved for Children With Gastroenteropancreatic Neuroendocrine Tumors

The FDA has expanded the approval of Lutathera (lutetium Lu 177 dotatate) to include pediatric patients with SSTR-positive GEP-NETs.

United statesTheodore laetschDevelopmental therapeutics programDrug administration

Novartis (NVS) Announces FDA Approval of Lutathera

Novartis (NVS) Announces FDA Approval of Lutathera
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United statesBaja californiaTheodore laetschTina deignanDrug administrationDevelopmental therapeutics programTherapeutic area headRadioligand therapy

Novartis radioligand therapy Lutathera® FDA approved as first medicine specifically for pediatric patients with gastroenteropancreatic neuroendocrine tumors

Approval based on NETTER-P trial in which Lutathera demonstrated a consistent safety profile and comparable drug exposure between pediatric and adult patients Gastroenteropancreatic neuroendocrine.

United statesBaja californiaMichael meoTina deignanTheodore laetschIsabella zinckRichard jarvisMarlena abdinoorNicole zinsli sommSloan simpsonParag mahantiSatoshi sugimotoImke kappesJonathan grahamElsevier incDrug administration