![]() There are currently 14 sites across the U.S. The EAP was opened in March 2016, and the first patient received the product in July. Expanded Access Program (EAP), in an effort to service the more urgent needs of NET patients. We remain steadfast in our efforts to resolve all of these outstanding issues as soon as possible. I published the latest Phase 3 results of the NETTER-1 trial – click here.Īs the review process for Lutathera® moves forward, we are increasing our U.S. I would like to reiterate that no additional clinical studies have been requested by the FDA, and aside from some open observations from facilities inspections, to date, the FDA has not made any comments on other sections of our NDA. Our team is in the process of addressing these requests. The FDA also requested some additional subgroup analyses and safety updates, as well as other stratification factors. It is our absolute focus and priority to deliver revised datasets meeting the FDA’s requirements as soon as possible. In September, we added a Head of Oncology in the U.S., who is already contributing enormously to this effort, and we are further strengthening our internal statistical capabilities, as well. To remediate these issues, we have formed an internal task force to work closely with an additional CRO and consulting statistician we hired that specialize in the exact areas highlighted by the FDA. I am also quite pleased to inform you that our team is already deeply engaged in the issues identified by the FDA in its recent communications regarding format, traceability, uniformity, and completeness of the NETTER-1 and Erasmus clinical datasets. I am pleased to share that the majority of these clarifications have since been provided, and the inspection of the CRO has been completed. As we announced in September, the EMA had requested some additional clarifications and an inspection of one of our contract research organizations (CRO), which modified the anticipated review to a standard timeline. “We are working closely with both the FDA and the European Medicines Agency (EMA) to address requests related to the review of our New Drug Application (NDA) and Marketing Authorization Application (MAA) for Lutathera®. We look forward to bringing the same enhanced patient management and convenience of a kit form to the European market with the launch of SomaKit TOC™ in 2017.” PRRT (Lutathera ®) This coding streamlines billing and reimbursement for all institutions using the product. The same Healthcare Common Procedure Coding System “A Code” will be used on claims to private payers. We are further encouraged by the granting of Transitional Pass-Through status by the Centers for Medicare & Medicaid Services (CMS) under an “A Code” for drug reimbursement. We have 13 radiopharmacies currently active and plan to expand to more than 40 sites over the first half of 2017. We are currently delivering more than 120 patient-ready doses of NETSPOT® per month, with the help of our national network of radiopharmacy partners. NET patient and physician community to our NETSPOT® launch has been very positive. In addition, we also recently announced approval of SomaKit TOC™ by the European Commission. product, NETSPOT®, a gallium Ga 68 dotatate PET diagnostic for neuroendocrine tumors (NETs), was approved. Food and Drug Administration (FDA), our first U.S. “In June 2016, after just 23 months from our pre-Investigational New Drug meeting with the U.S. The original projected approval date for Lutathera ® (PRRT) was by but to the best of my knowledge, no new date has been published and none was listed in this progress report. I found the content very positive and let me say that the header to the report was entitled “….Asserts Confidence in Ability to Address FDA Comments on Lutathera® NDA“. There is some really useful information, particularly for those looking for updates on PRRT (Lutathera ®). I’ve added additional comment where necessary to provide a richer picture. Here’s some extracts from the CEO of Advanced Accelerator Applications 2016 Progress Report published on. ![]()
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