The primary endpoint of the study was progression-free survival (PFS).
All patients had somatostatin receptor-positive tumors, the majority of which were grade 4 on the Krenning scale (60%). The primary tumor site was the ileum (74%) and the most common sites of metastasis were the liver (84%), lymph nodes (66%), and other locations (35%). The mean age of patients in the investigational arm was 63 years (☙) and the mean BMI was 25 (±5). In the control arm, patients received octreotide LAR at 60 mg every 4 weeks.īaseline characteristics were well balanced between the two arms. Four doses of Lutathera were administered at 7.4 GBq every 8 weeks in combination with octreotide at 30 mg for symptom control. Patients with midgut NETs who progressed on standard-dose octreotide (30 mg) were randomized to Lutathera (n = 116) or high-dose octreotide (n = 113). The NDA is based on the phase III NETTER-1 trial, which compared Lutathera with high-dose octreotide LAR for patients with grade 1 or 2 metastatic midgut NETs.2 In this trial, there was a 79% reduction in the risk of progression or death with Lutathera compared with octreotide. The letter did not request the initiation of additional studies of Lutathera. The CRL, which followed a discipline review letter issued in November 2016, requested new subgroup data, a safety update, and that revisions be made to the previously submitted data. However, on December 21, 2016, Advanced Accelerator Applications, reported that the FDA had issued a complete response letter (CRL) informing the company that the NDA for Lutathera would need to be resubmitted. The FDA had granted a priority review designation to the NDA for Lutathera in June 2016, and had been scheduled to make its final decision by December 28, 2016.
#Netspot novartis update#
UPDATE : FDA Approves Lutathera for GEP-NETs Under the Prescription Drug User Fee Act, the FDA is scheduled to make a final approval decision by January 26, 2018. The FDA is currently reviewing a new drug application (NDA) for Lutathera for patients with GEP-NETs. “With Lutathera, we can build on this legacy by expanding the global reach of this novel, differentiated treatment approach and work to maximize Advanced Accelerator Applications broader RLT pipeline and an exciting technology platform.” “Novartis has a strong legacy in the development and commercialization of medicines for neuroendocrine tumors where significant unmet need remains for patients,” Bruno Strigini, CEO, Novartis Oncology, said in a press release. The pharmaceutical giant said the deal would boost its oncology presence with “both near-term product launches as well as a new technology platform with potential applications across a number of oncology early development programs. Novartis plans to fund the deal through external short- and long-term debt.
This offer values the company at $3.9 billion. AAA had sales of €109 million in 2016.ĪAA’s board of directors has already approved a memorandum of understanding stating that Novartis will make a cash offer of $41 per ordinary share of AAA and $82 per American Depositary Share, each representing 2 ordinary shares, subject to certain conditions. In addition to Lutathera, the company has also developed the companion diagnostics NETSPOT and SomaKit TOC. The EU approved Lutathera for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in September. Novartis has announced a planned $3.9-billion acquisition of Advanced Accelerator Applications (AAA), a radiopharmaceutical company that develops, produces, and commercializes Molecular Nuclear Medicines.ĪAA manufactures Lutathera (lutetium oxodotreotide), a first-in-class RadioLigand Therapy (RLT) product for neuroendocrine tumors (NETs).
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