![]() octreotide long-acting), which cannot be interrupted for at least 6 weeks before the administration of Lutathera. Hyperkaleamia > 6.0 mmol/L (CTCAE Grade 3) which is not corrected prior to study enrolmentĪny patient receiving treatment with short-acting octreotide, which cannot be interrupted for 24 h before and 24 h after the administration of Lutathera, or any patient receiving treatment with SSAs (e.g. Uncontrolled diabetes mellitus as defined by hemoglobin A1c value > 7.5% Serum albumin 470 msec for females and QTcF > 450 msec for males or congenital long QT syndrome Patients who have provided a signed informed consent form to participate in the study, obtained prior to the start of any protocol related activities Presence of at least 1 measurable site of disease The tumor uptake observed in the target lesions must be > normal liver uptake. NETSPOT®), Somatostatin Receptor scintigraphy (SRS) with -pentetreotide (Octreoscan® SPECT/CT), SRS with -Tektrotyd, -DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging. Somakit-TOC®) PET/CT (or MRI when applicable based on target lesions) imaging, -DOTA-TATE PET/CT (or MRI when applicable based on target lesions) imaging (e.g. Patients ≥ 15 years of age and a body weight of > 40 kg at screeningĮxpression of somatostatin receptors on all target lesions documented by CT/MRI scans, assessed by any of the following somatostatin receptor imaging (SRI) modalities within 3 months prior to randomization: -DOTA-TOC (e.g. The Swiss big pharma company has been steadily bulking up in cancer via bolt-on acquisitions, for example by buying up GlaxoSmithKline’s oncology assets in 2015 in a $16bn deal, acquiring US biopharma Admune Therapeutics and announcing a string of licensing deals for cancer candidates, mainly in immuno-oncology.Presence of metastasized or locally advanced, inoperable (curative intent) histologically proven, well differentiated Grade 2 or Grade 3 gastroenteropancreatic neuroendocrine (GEP-NET) tumor diagnosed within 6 months prior to screening. Latterly Sandostatin has played second fiddle to Afinitor, which is rolling out in multiple NET tumour types including gastrointestinal and lung NET last year and brought in $1.1bn in the same period. The popularity of a long-acting version means it It’s still a big earner for Novartis however, with sales of around $1.2bn in the first nine months of this year, down just 4%. Novartis has no heritage in this type of medicine but already markets two drugs for NET – Sandostatin (octreotide) and Afinitor/Votubia (everolimus) – so the acquisition makes sense from a franchise perspective, particularly as Sandostatin has now lost patent protection for the immediate-release formulation. AAA was spun out 15 years ago from Cern, the European nuclear research organisation. ![]() With the acquisition, Novartis is aiming to add AAA’s Lutathera (Lutetium Lu177 dotatate) for treating gastroenteropancreatic neuroendocrine tumours (NET) – approved in the EU and heading for an FDA decision towards the end of January – plus two commercial NET imaging agents (NetSpot and Somakit) already generating revenues.Īdded to that, the acquisition adds a pipeline of early-stage radionuclide candidates for other types of cancer, including several solid tumours including prostate cancer. The tender offer will expire at midnight on January 19 unless extended, said Novartis. Novartis offer to buy the company was made in October and – after negotiations with company’s works council – AAA’s board has now given its blessing to the $41 per share takeover, which values the French company at $3.9bn. Novartis has started its cash tender offer for French firm Advanced Accelerator Applications, which specialises in radiopharmaceuticals to treat cancer.
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