A phase II trial of Octreotate-Lu-177-DOTA-Tyr-3 in patients with various inoperable, somatostatin receptor positive NETs including bronchial carcinoid tumors
Active, no longer recruiting
Phase of Trial: Phase II
Latest Information Update: 27 Jul 2017
At a glance
- Drugs Octreotate-Lu-177-DOTA-Tyr-3 (Primary)
- Indications Carcinoid tumour; Neuroendocrine tumours; Paraganglioma; Phaeochromocytoma
- Focus Adverse reactions; Therapeutic Use
- 27 Jul 2017 According to an Advanced Accelerator Applications media release, the company has resubmitted the New Drug Application for Lutathera to the US Food and Drug Administration. The company has resubmitted the NDA following receipt of a complete response letter from the FDA in December 2016, in which the Agency cited issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets.
- 21 Jul 2017 According to an Advanced Accelerator Applications media release, the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion recommending the marketing authorization of lutetium (177Lu) oxodotreotide (Lutathera) for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) in adults.
- 20 Apr 2017 Results (n=1053) published in the Clinical cancer research: an official journal of the American Association for Cancer Research.