PRRT is generally well tolerated but, long-term PRRT side-effects, in particular renal failure and hematological toxicity, is reported ( Bodei et al., 2008 Imhof et al., 2011 Bergsma et al., 2018). On the basis of this approval, GEP-NET patients can be treated with PRRT as a second-line treatment, after failure of first-line treatment with SSAs. Francesco Panzuto, in Reference Module in Biomedical Sciences, 2022 Patient inclusion criteriaĪs a result of the publication of the NETTER 1 phase 3 study, PRRT with 177Lu-oxodotreotide (Lutathera®) is currently approved for adult patients with unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) ( Strosberg et al., 2017). AAA had sales of EUR 109 million in 2016.Alberto Signore. In addition to Lutathera, AAA brings a broad set of skills in developing, manufacturing and commercializing radiopharmaceuticals, including the companion diagnostics for Lutathera (NETSPOT and SomaKit TOC). with a Prescription Drug User Fee Act (PDUFA) date of 26 January 2018. Lutathera was approved in Europe in September 2017 for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (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," said Bruno Strigini, CEO, Novartis Oncology. The transaction would strengthen Novartis' 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. Radiopharmaceuticals, such as Lutathera, are unique medicinal formulations containing radioisotopes which are used clinically for both diagnosis and therapy. AAA is a radiopharmaceutical company that develops, produces and commercializes molecular nuclear medicines including Lutathera (177Lu-DOTATATE), a first-in-class RLT product for neuroendocrine tumours (NETs). Novartis has entered a memorandum of understanding with Advanced Accelerator Applications (AAA) under which Novartis intends to commence a tender offer for 100% of the share capital of AAA subject to certain conditions. Watch video The Future of Biomanufacturing: Capacity, Capability and Careers February 22, 2022.Watch video Rapid Tech Transfer of Vaccine Products February 24th, 2022.Watch video Technology & Device Trends Driving Care from Hospital to Home March 29th, 2022.Watch video The Road to Pharmapack Europe 2022.Watch video How Small/Mid-Size Firms are Shaping the Healthcare M&A Market April 28th, 2022.Watch video The Digitalization of Autoinjector Manufacturing Webinar June 22nd, 2022.Watch video Common Stumbling Blocks When Outsourcing an Injectable Project to a CMO and How to Avoid Them June 28th, 2022.Watch video Consumer Health Trends – Listening to the Gut July 28th, 2022.Watch video Improved Delivery of Poorly Soluble Compounds Using Capsule Formulations August 25th, 2022.Watch video Why the Excipients Market Needs to Embrace the New Normal 31 August 2022.REGISTER NOW Innovating or Stagnating? Reviewing the Current State of Pharma in Europe 25th October 2022. ![]() REGISTER NOW The Digital Revolution of Animal Health September 15th 2022.
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