Neuroendocrine Neoplasms: A riddle wrapped in a mystery inside an enigma
The riddle.For many years, I've been reading and blogging about Neuroendocrine Neoplasms, NENs for short. NEN is a relatively new term which came after my diagnosis. Nomenclature is still evolving and there is always something to learn. It's also true to say the term 'Neuroendocrine Neoplasms' is the same as saying 'Neuroendocrine Cancer'. These neoplasms are cancers that begin in specialised cells called 'neuroendocrine cells'. Neuroendocrine cells have traits similar to those of nerve cells and hormone-producing cells, particularly the latter. In face one NET specialist said "While the name “neuroendocrine” implies that these tumors involve both nerve cells and…
Genetics and Neuroendocrine Tumors
Hereditary genetics.....where to focusIn recent years, it has become increasingly apparent that a number of Neuroendocrine tumours arise as a result of germline genetic mutations and are inherited in an autosomal dominant pattern. The number of genes implicated is increasing as research advances and I cannot guarantee this post will contain all of them.Apparently, 5-10% of NETs are estimated to have a hereditary background. Hereditary syndromes associated with these include Multiple Endocrine Neoplasia (MEN), Von Hippel Lindau (VHL), Neurofibromatosis Type 1 (NF1), Tuberous Sclerosis (TS) and others. People who have a genetic condition may present with the tumours (perhaps along…
Phase 3 Clinical Trial of PRRT ITM11 177Lu-Edotreotide – COMPETE for GEPNETs
Update - 13th November 2025. ITM Announces FDA Acceptance of New Drug Application (NDA) and PDUFA Date for n.c.a. ¹⁷⁷Lu-edotreotide (ITM-11) in Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)Garching / Munich, Germany, November 13, 2025 - ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) completed its filing review and accepted the company’s New Drug Application (NDA) for n.c.a. 177Lu-edotreotide (also known as ITM-11 or 177Lu-edotreotide). 177Lu-edotreotide is ITM’s proprietary, synthetic, targeted radiotherapeutic investigational agent for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date…
Electronic Autoinjector for Somatuline® Autogel® / Somatuline® Depot (lanreotide)
Update 4th September 2024. I have been informed by a third party and trusted source that this upgrade to Lanreotide Ipsen injection device which I published in 2022, will not happen. Apparently, the project announced in 2022 never really got off the ground. My own guess is that Ipsen's business case expenditure was too much risk given the rise of the generic Lanreotide meds around the same time, i.e. the return of investment (ROI) would not be recouped.I do not understand why Ipsen did not offer a lower price to remain competitive in UK and elsewhere. It makes me think that…
Neuroendocrine Cancer: Glossary of Terms
Welcome to my Neuroendocrine Cancer terms and definitions list providing a source of meanings for acronyms and medical terms, all sourced from top Neuroendocrine Cancer sites. How to use this list: 1. If your term begins with an A, see the list of As etc. Ditto for B to Z. Select your term from the list, the definition will show along with any of my blogs where that term is mentioned – this adds context. . 2. Numerical terms are also listed. Please note I’m constantly working on the repository to clean up all definitions, adding and removing links where necessary, and…
Lanreotide for Lung NETs – SPINET Clinical Trial
Reviewed and updated 30th July 2024. Phase III trial data update. Update 30th July 2024. This trial had a low particpation repsonse. Experts cited the main reason was the increasing use of SSAs for Typical and Atypical Lung NETs in clinical practice; as such, patients were reluctant to enroll in this study, with the risk of receiving a placebo, when they could access the active treatment with a prescription. The above is unfortunate but perhaps the wording of some approvals caused confusion about scope. Together with pragmatic compassionate use in cliniclal practice this has perhaps had an adverse affect in…
I’m still here
I wasn't supposed to be here but I am. I was diagnosed with metastatic Neuroendocrine Tumours (NETs) on 26th July 2010. Until I arrived at my 5th anniversary, I hadn't thought much about how (or if) I should mark these occasions. I never thought I would dwell on such things as 'Cancerversaries' but I now totally get why many patients and survivors do.There are several types of 'Cancerversary' that for some, could trigger a mix or range of emotions including gratitude, relief and fear of cancer recurrence or growth. These milestones could be the date of a cancer diagnosis, the end…
Neuroendocrine Cancer – the diarrhea jigsaw
Reviewed and updated 5th July 2024 Diarrhea can be a symptom of many conditions, but it is particularly key in Neuroendocrine Tumour (NET) Syndromes and types, in particular, so called Carcinoid Syndrome but also in those associated with various other NET types such as VIPoma, Gastrinoma, Somatostatinoma, Medullary Thyroid Carcinoma, PPoma. Secondly, it can be a key consequence (side effect) of the treatment for Neuroendocrine Tumours and Carcinomas, in particular following surgery where various bits of the gastrointestinal tract are excised to remove and/or debulk tumour load. There are other reasons that might be causing or contributing, including (but not…
The 50 shades of Neuroendocrine Neoplasms
If you read any authoritative source on this cancer, it will normally begin with "Neuroendocrine Neoplasms (NENs) are a group of heterogeneous tumours .............". The term heterogeneous means diverse in character or content; or a structure with dissimilar components or elements. This is not surprising as these tumours are found in Neuroendocrine cells throughout the vast majority of the human anatomy. And yet, when you look at many hospital/healthcare sites, advocate organisation sites, and cancer information sources not maintained by Neuroendocrine Cancer scientists or specialists, you might start to think there is just one big type of NET and only…
Neuroendocrine – what’s that?
I once met some fellow cancer advocates and the conversation turned to what inspired us to ‘do what we do’. When it came to my turn as the only Neuroendocrine Cancer patient, I was already prepared to regurgitate my usual 'spiel'. As sometimes happens, a listener queried me with the words "Neuroendocrine - what's that?". Another focused on 'Neuro' enquiring whether my nervous system or my brain had somehow become cancerous. Deja vu - here we go again! Two days later, I was speaking to one of my online friends who was having similar problems explaining this cancer to family and…
Carcinoid vs Neuroendocrine
OPINION - There's a constant debate regarding the validity of the term 'Carcinoid'. I've posted about this a few times and as far as I know, the debate has been raging for some years. This post was originally generated in April 2015 (and hasn't changed that much!). EDIT MARCH 2024. There is now a consolidated Endocrine/Neuroendoceine Tumour classification system (Blue Book). Still in print but you can see a summary of changes by clicking here. This change should provide some leverage to Neuroendocrine committees particularly about what things should be called. EDIT MARCH 2022. The latest classification system for Lung…
FDA Accepts New Drug Application for Generic Lutetium Lu 177 Dotatate (177Lu-PNT2003) in GEP-NETs
Breaking News. We have generic somatostatin analogues, generic targeted therapy, and I guess it was only a matter of time until we got generic PRRT (Radioligand Therapy) e.g. generic Lutetium Lu 177 dotatate. This news begins that process which is also based on a clinical trial which took place in Canada (195 participants) and which now appears to be complete. The announcement comes from US but if this is realised, you can expect it to be available in many other countries and continents where there is a market. This may even drive down prices and/or increase availability. The FDA has…
There are no perfect answers about an imperfect cancer
If you read any authoritative source on this cancer, it will normally begin with "Neuroendocrine Neoplasms (NENs) are heterogeneous tumours .............". The term heterogeneous means diverse in character or content; or a structure with dissimilar components or elements. This is not surprising as these tumours are found in Neuroendocrine cells throughout the vast majority of the human anatomy.This represents a challenge for regular healthcare professionals but also for Neuroendocrine Neoplasm specialists who are answering many questions asked by patients and their loved ones on a daily basis. I very much suspect this challenge is the same for many types of…
First and only FDA-cleared, fully automated chromogranin A assay
There has been controversy about the utility of Chromogranin A for many years now. Specialists have been critical about its use but to be fair even those less critical still confirm that alone it would not be trusted to formally diagnose Neuroendocrine Cancer. That said, it was still controversial when certain US guidelines were updated to recommend it is not regularly tested. It's well known for being a sensitive but non-specific marker for most tumours of Neuroendocrine type, the non-specificity is mostly due to the other conditions, some of which are highly prevalent in many countries, including but not limited to…
Clinical Trial: Novel Somatostatin Receptor Subtype 2 Antagonist Labelled With Terbium-161 (161Tb-DOTA-LM3)
Update 14th December 2025 - Results from the Phase 0 proof of concept trial. Conclusion [161Tb]Tb-DOTA-LM3 shows a 7.6-fold-higher tumor absorbed dose than that found when using [177Lu]Lu-DOTATOC. The tumor–to–bone marrow absorbed dose ratio was in the same range for both radiopharmaceuticals. The promising dosimetry and safety results from this phase 0 study will lay the foundation for further clinical development of [161Tb]Tb-DOTA-LM3. Dose-escalation trials and peptide dose optimizing studies are warranted to establish the maximum tolerated activity per cycle and assess long-term efficacy. The integration of 161Tb into PRRT regimens has the potential to redefine the therapeutic landscape for NETs,…
RonnyAllan.NET – a review of 2022
ReviewIn 2022, my pet project (my blog) hit 2 million views in early November – that was a major boost. It takes 3-4 years to get a million hits based on current performance. To be honest, I’m still flabbergasted by reaching one million in 2018. It just kinda happened! I am grateful for every single view. 2022 was a challenging year, mainly because the pandemic had some latent impact on my social media activity and also in terms of growth. 2020 and 2021 were slower than normal but 2022 has seen some pickup. Some of it is due to less writing but much…
Survival Outcomes in Metastatic Gastroenteropancreatic Neuroendocrine Tumor Patients receiving Concomitant 225Ac-DOTATATE Targeted Alpha Therapy and Capecitabine: A Real-world Scenario Management Based Long-term Outcome Study
Introduction I've written about both 225Ac-DOTATATE targeted alpha therapy (TAT) and Capecitabine before but never as a concomitant pair (combo). So, when this Indian study came up on my radar, I felt it was a useful addition to my website adding to my existing targeted alpha therapy portfolio of information. India appears to be using more of this type of PRRT than any other country. Read more about targeted alpha therapy by clicking here or on the photo below. Read more about Capecitabine (combo with Temozolomide) by clicking here or on the photo below. The abstract from the Indian study…
Lutetium 177Lu-Edotreotide Versus Best Standard of Care in Well-differentiated Aggressive Grade-2 and Grade-3 GastroEnteroPancreatic NeuroEndocrine Tumors (GEP-NETs) – (COMPOSE)
Garching / Munich, October 27, 2022 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company, today announced that the U.S. Food and Drug Administration (FDA) has granted the company Fast Track designation for ITM-11 (n.c.a. 177Lu-edotreotide), an investigational radiopharmaceutical for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs). ITM-11 is being evaluated as a Targeted Radionuclide Therapy in two phase III clinical trials, COMPETE and COMPOSE. The FDA Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and address an unmet medical need. The purpose is to bring new and promising medicines to patients sooner. The…
Dual Tracer (68Ga-DOTATATE and 18F-FDG) PET Imaging in G2 & G3 Gastroenteropancreatic Neuroendocrine Tumours
For some time now, I've been watching the development of PET scans for Neuroendocrine Neoplasms (NENs). I use the term 'Neoplasms' because there are different strategies for well and poorly differentiated types, Neuroendocrine Tumour (NET) and Neuroendocrine Carcinoma (NEC) respectively.It's known that most NETs have somatostatin receptors which makes tumours be seen better on somatostatin receptor-based imaging e.g. 68Ga-DOTATATE or 64Cu DOTATATE, but more aggressive types tend not to have working somatostatin receptors and are better seen on regular PET, i.e. 18F-FDG PET/CT. However, nothing in NENs is simple and there's always outliers. This has been highlighted since the addition…
Selecting patients and the Challenges of Evaluating Response to PRRT in GEPNETs: The Present and the Future
Share on facebook Facebook Share on twitter Twitter Share on pinterest Pinterest Share on whatsapp WhatsApp Share on email Email Fascinating article from the Italian NET scientific community. This article is more than just what the title says, it provides overviews on many facets of NETs including markers, scans and PRRT itself. It covers how to select patients for PRRT in the first place, i.e. who is most likely to get a good response to this treatment and then look at how to track and assess that response. The important thing I gathered from reading is that none of this…
My interview with ITM – I’m still here!
Facebook X Pinterest WhatsApp Email I was delighted to be contacted by ITM AG, a Germany based pharmaceutical company specialising in targeted radionuclide technology in precision oncology (e.g. Peptide Receptor Radionuclide Therapy - PRRT). The company is formally known as ITM Isotopen Technologien München. One of their pipeline developments is 177Lu-Edotreotide in patients with neuroendocrine tumors of gastroenteric or pancreatic origin (GEP-NET). The development is via the COMPETE Phase III Clinical Trial which is being conducted worldwide in 11 countries at 33 sites and is open for recruitment. I actually wrote about this trial after attending a workshop at the…
Clinical Trial SPARTALIZUMAB – Immunotherapy for Neuroendocrine Neoplasms (PDR001)
UpdateTrial complete. Conclusion abstract - Single agent PD-1/PD-L1 inhibitors have not demonstrated clinical utility in an unselected NET population and should not be used outside of clinical trials. The potential for PD-L1 inhibition in the thoracic cohort warrants further investigation. Read more here. PDR001 (anti-PD-1) is an investigational immunotherapy being developed by Novartis to treat both solid tumors and lymphomas (cancers of the blood). It is currently being trialled on many cancers including Neuroendocrine. Its brand name is SPARTLIZUMAB.How PDR001 worksPDR001 is a type of immunotherapy, meaning that it acts by activating the body’s own immune system to recognize and fight…