Here’s some extracts from the CEO of Advanced Accelerator Applications 2016 Progress Report published on 9 Jan 2017. I’ve added additional comment where necessary to provide a richer picture. There is some really useful information, particularly for those looking for updates on PRRT (Lutathera®). 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“. The original projected approval date for Lutathera® (PRRT) was by 28 Dec 2016 but to the best of my knowledge, no new date has been published and none was listed in this progress report.
“In June 2016, after just 23 months from our pre-Investigational New Drug meeting with the U.S. Food and Drug Administration (FDA), our first U.S. product, NETSPOT®, a gallium Ga 68 dotatate PET diagnostic for neuroendocrine tumors (NETs), was approved. In addition, we also recently announced approval of SomaKit TOC™ by the European Commission. The response of the U.S. NET patient and physician community to our NETSPOT® launch has been very positive. We are currently delivering more than 120 patient-ready doses of NETSPOT® per month, with the help of our national network of radiopharmacy partners. We have 13 radiopharmacies currently active and plan to expand to more than 40 sites over the first half of 2017. 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. The same Healthcare Common Procedure Coding System “A Code” will be used on claims to private payers. This coding streamlines billing and reimbursement for all institutions using the product. (I published more – click here). 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.”
“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®. 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. I am pleased to share that the majority of these clarifications have since been provided, and the inspection of the CRO has been completed. 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. 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. 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. It is our absolute focus and priority to deliver revised datasets meeting the FDA’s requirements as soon as possible. The FDA also requested some additional subgroup analyses and safety updates, as well as other stratification factors. Our team is in the process of addressing these requests. 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. 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.
As the review process for Lutathera® moves forward, we are increasing our U.S. Expanded Access Program (EAP), in an effort to service the more urgent needs of NET patients. The EAP was opened in March 2016, and the first patient received the product in July. There are currently 14 sites across the U.S. participating in the EAP for Lutathera® in Arizona, California, Colorado, Iowa, Massachusetts, Missouri, New York, North Carolina, Pennsylvania, and South Carolina. Additional sites are expected to enrol in 2017. European compassionate use and named patient programs for Lutathera® already span 67 centers across 10 countries: Austria, Denmark, Estonia, Finland, France, Greece, Portugal, Spain, Switzerland, and the United Kingdom. More than 1,500 patients worldwide have been treated with Lutathera® through these programs.”
“Our enhanced supply chain and manufacturing capabilities will further support this activity and prepare us for Lutathera’s® launch. Our acquisition of IDB Group in the Netherlands, in January 2016, provided AAA with a reliable supply of Lutetium 177 for the production of Lutathera®, as well as production capabilities for other future product candidates. Additionally, our first U.S. manufacturing and distribution facility in Millburn, NJ was completed this summer. This site currently distributes NETSPOT® kits for reconstitution and Oxygen-18 enriched water, and is undergoing validation for production of Lutathera®. The Millburn site is expected to supply Lutathera® to the entire North American market.”
“In July 2016, we signed a clinical trial agreement with the National Cancer Institute (NCI), whereby NCI will sponsor and conduct a study of Lutathera® in patients with inoperable pheochromocytoma and paraganglioma. In a Phase II trial conducted at the Erasmus Medical Center, that is part of our NDA and MAA, 45 patients with these indications were treated with a median Progression Free Survival of 24.8 months and a median Overall Survival that was not reached. We hope these results will be confirmed by the NCI trial. There are six additional investigator initiated studies currently ongoing with Lutathera® in indications such as primary refractory or relapsed high risk neuroblastoma; FDG-positive and negative gastroenteropancreatic , or GEP-NETs; and unresectable, progressive, well-differentiated neuroendocrine pancreatic carcinoma, with more planned in 2017.”
“As we enter 2017, we believe AAA is well positioned to achieve our goals. We have the infrastructure and capabilities to build on our success with NETSPOT®, and implement product launches for SomaKit TOC™ and then Lutathera®. We are increasing market penetration in both the U.S. and Europe. We continue to generate positive clinical data for Lutathera® and have a robust development pipeline. We are well capitalized to execute our strategy and secure our leadership as a key innovator in the Molecular Nuclear Medicine segment. I thank our stakeholders for their continued support, and look forward to providing updates on our progress with the FDA’s requests.”
End of extract ——————————-
I hope this extract of the Neuroendocrine Cancer aspects of the report is useful. However, if you wish, you can read the whole report here. I look forward to informing you that the US FDA has approved PRRT (Lutathera®).
If you want to read a history of PRRT, please see the excellent series published by Carcinoid Cancer Foundation entitled Lutathera® – The Journey from Homegrown Therapy to Registered* Pharmaceutical Treatment for NETs
Thanks for reading
Ronny Allan
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