Drug ApprovalPhase 2Orphan DrugAcquisitionRadiation Therapy
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Source: Pharmaceutical Technology
Lutathera is a peptide receptor radionuclide therapy that uses high-dose radiation to target and destroy cancer cells. Image Credit: JHVEPhoto / Shutterstock.
Lutathera is a peptide receptor radionuclide therapy that uses high-dose radiation to target and destroy cancer cells. Novartis added Lutathera to its portfolio as part of the $3.9bn acquisition of Advanced Accelerator Applications in 2017.
The radionuclide therapy is one of the top 20 brands for Novartis; it generated $169m in sales in Q1 this year, per the company’s financials. Sales for Lutathera are expected to increase to over $879m in 2030, as per GlobalData analysis.
Novartis reports 25% increase in net income in Q1 2024
Preview
Source: Pharmaceutical Technology
The US FDA approval decision was based on the data from the open-label Phase II NETTER-P trial (NCT04711135). The trial enrolled 11 patients aged 12–18 years with either GEP-NETs or pheochromocytoma and paraganglioma (PPGL), which are neuroendocrine tumours of the adrenal glands and paraganglia, respectively.
Novartis did not disclose the detailed results of the trial but noted that the safety profile was consistent with the results of NETTER-1 study (NCT04954820) that studied adults with this same condition. The company said that the “estimated radiation absorbed dose in paediatric patients was within established organ thresholds for external beam radiation and comparable to that in adults for the approved dose”.
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