Thanks for reading
Awareness of Neuroendocrine Cancer and associated issues. Supporting and helping NET Patients
ASCO (American Society of Clinical Oncology) is one of the biggest cancer conferences in the world normally bringing together more than 30,000 oncology professionals from around the world to discuss state-of-the-art treatment modalities, new therapies, and ongoing controversies in the field. As Neuroendorine Tumors is on a roll in terms of new treatments and continued research, we appear to be well represented with over 20 ‘extracts’ submitted for review and display. This is fairly complex stuff but much of it will be familiar to many. I’ve filtered and extracted all the Neuroendocrine stuff into one list providing you with an easy to peruse table of contents, complete with relevant linkages if you need to read more. For many the extract title and conclusion will be sufficiently educational or at least prompt you to click the link to investigate further. Remember, these are extracts so do not contain all the details of the research or study. However, some are linked to bigger trials and linkages are shown where relevant. I’ve also linked to some of my blog posts to add context and detail.
I’m hoping to capture any presentations or other output from the meeting which appears to be relevant and this will follow after the meeting. I will also be actively tweeting any output from the live event (for many cancers, not just NETs).
There’s something for everyone here – I hope it’s useful.
Thanks for reading
UPDATED 30 Oct 2017. Novartis and Advanced Accelerator Applications Announced on 30 October 2017 that Novartis is buying the company. Read here
UPDATED 29 Sep 2017. Advanced Accelerator Applications Announced on 29 September that the European Commission has approved the use of Lutetium Lu 177 Dotatate (Lutathera®). Despite the treatment being used for over 10 years, this is apparently the first ever approval of the therapy. EU constituent countries are now free to fund and implement services. In the UK, now awaiting action by NICE (see announcement below 3rd and 11th Aug). Read here
UPDATED 28 Aug 2017. Advanced Accelerator Applications Announced on 28 August that the new Prescription Drug User Fee Act (PDUFA) date for Lutetium Lu 177 Dotatate (Lutathera®) would be January 26, 2018. Read here
UPDATED 11 Aug 2017. AAA responds to UK drug appraiser National Institute for Health and Care Excellence (NICE) negative recommendation. Read here
UPDATED 3 Aug 2017. Currently, NICE (the UK equivalent of FDA) are not recommending Lu-177 Lutathera based on cost. This is only a draft recommendation and another announcement is expected end Sep 2017. More to follow when known. This is a blow for patients in England. Read here
Original post continues …..
There’s a lot of questions doing the rounds on forums and messages about the approval of Lutathera (PRRT) in USA, Europe and other places. What we actually know is in the red print headlines above.
The UK situation is interesting because the EMA “market authorisation” received a positive indication on 20th July and once the marketing authorisation is in place, the decision to fund the drug will be with national approval organisations. The positive indication reads “Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults”. Despite a European Commission (EC) approval on 29 Sep 2017, NICE are currently not recommending PRRT (Lu-177) due to what looks like cost grounds. One theory is that this is a metaphor for price negotiation between NHS and AAA. This is particularly controversial issue for UK as the drug was removed from routine use (Cancer Drugs Fund) in 2015. Why wait in UK? There are ways to get access to PRRT via different funding sources. Ask your specialist because this possibility is unfortunately not very well publicised.
The situation in USA looks more favourable, most likely due to the different healthcare system in place (although whether insurance companies will sign up or be quick to sign up, is another question). My guess is it will be approved by 26 Jan 2018. Why wait in USA? There an extended access program in place
Of course, these diagnostic and treatment tools have been in use in Europe for some time but to be honest, they have been on a limited scale and never formally approved by national drug agencies. In UK, it was even removed from routine availability through a ‘slush fund’ formally known as the Cancer Drugs Fund – to cut a long story short, that dried up. There are still ways of obtaining the treatment but certain criteria apply. In the meantime, I constantly see stories of US patients travelling to Switzerland, Germany and England; and Irish patients travelling to Sweden. I’m sure there’s people from other countries also travelling to other countries! However, it does indicate one thing, there is a huge unmet need in that many patients do not have access to the best treatments in their own country. I see this daily through many private messages.
Understanding the terminology is half the battle in understanding the latest radionuclide developments. I’ve included Ga-68 PET scans in this and you will see the linkages as you read on.
NETSPOT is the radionuclide mix for use in Gallium 68 (Ga-68) PET diagnostic scans and was recently approved in USA. SOMAKIT TOC is essentially the European equivalent of NETSPOT and is already approved in Europe.
LUTATHERA is the radionuclide mix for use in Peptide Radio Therapy Treatment (PRRT). It is still waiting for approval in USA. The delay is due to an issue with the data. To the best of my knowledge, there is no new forecast decision date for approval (……I have a view it might arrive at quite short notice). You may also see this drug called Lutetium or Lu-177 dotatate.
Together they form a ‘theranostic pair’. Theranostics is a joining of the words diagnostics and therapy. Theranostics is apt as together (NETSPOT / SOMAKIT TOC and Lutathera), both target NETs expressing the same somatostatin receptor, with Lutathera intended to kill tumor cells by emitting a different kind of low-energy, short-range radiation than that of the diagnostic version.
Moreover, thanks to the theranostic approach that nuclear medicine allows, AAA’s NETSPOT/SomaKit TOC products will be able to determine when Lutathera is the appropriate treatment.
You can read a previous update of AAA’s approach to diagnostic and therapy tools for NETs by clicking here.
While AAA has no plans to partner on Lutathera for future indications, it may continue doing so, and the next pair of drugs it is seeking to bring to market, 177Lu-PSMA-R2 and complementary diagnostic 68Ga-PSMA-R2, is addressing prostate cancer, so a much larger patient group. Already this approach is showing promise in Germany. German laws allow sometimes faster access to novel technologies in the field of nuclear medicine, and so there has been an uptake of the diagnostic examination. AAA believes many thousands of patients have been already diagnosed using a PSMA-guided compound.
Here’s an extract from AAA’s development timeline
177Lu-PSMA-R2 and 68Ga-PSMA-R2. 177Lu-PSMA-R2 and 68Ga-PSMA-R2 are in development to treat, image, monitor and stage prostate cancer. 177Lu-PSMA-R2 will be aimed at treating and monitoring prostate cancer and 68Ga-PSMA-R2 should act as its companion diagnostic and help diagnose and stage the disease. AAA has signed an exclusive license agreement with Johns Hopkins University in Baltimore, Maryland to develop and market PSMA-R2, in prostate cancer.
177Lu-NEOBOMB1 and 68Ga-NEOBOM1. NeoBOMB1 is a unique new generation antagonist bombesin analogue targeting GRPR-expressing malignancies. Our plan is to radiolabel NeoBOMB1 to develop a theragnostic pair: 177Lu-NeoBOMB1 for treatment and a 68Ga-NeoBOMB1 for diagnosis. AAA has signed an exclusive license agreement with Erasmus University Medical Center (UMC) and Demokritos National Center for Scientific Research to develop NeoBOMB1. AAA is currently planning three clinical studies in different indications including gastrointestinal stromal tumors, prostate cancer and breast cancer.
France-headquartered Advanced Accelerator Applications (AAA) is different not just because of its confidence in molecular nuclear medicine, but also because of its theranostic approach, chief executive Stefano Buono tells The Pharma Letter.
The company is already a European leader in the production and commercialization of molecular nuclear diagnostic radiopharmaceuticals for positive emission tomography (PET) and single-photon emission computed tomography (SPECT), but it could make waves in different circles with this unique strategy – integrating diagnostics and therapeutics.
Big pharma is likely to have an eye on AAA’s theranostic approach to neuroendocrine tumors (NETs), involving imaging of NETs expressing a specific somatostatin receptor using the company’s NETSPOT/SomaKit TOC diagnostics, and treatment of such tumors using its therapeutic, Lutathera (Lutetium Lu 177 dotatate).
Both target NETs expressing the same somatostatin receptor, with Lutathera intended to kill tumor cells by emitting a different kind of low-energy, short-range radiation to the diagnostic.
While NETSPOT and SomaKit TOC are already approved in the USA and Europe, respectively, Lutathera applications are currently under review, with orphan status, by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA).
If AAA was to reach the market with Lutathera, the company’s route to becoming a drug developer would be an unconventional one.
It was set up by Mr Buono, a physicist by background, in 2002 to develop a patent from the European Organization for Nuclear Research (CERN) in the radioisotope production field.
“This opportunity gave me the possibility to understand the nuclear medicine market and at that time a new modality of imaging was explored – that was PET,” he recalls.
“The drug for that modality, that had to be injected into patients for the imaging, was complicated to manufacture. You needed a particle accelerator, and they had only a 10 hour shelf-life, so it needed a completely new model. I took the challenge to create an industrial model for those drugs in Europe – we had only a couple of examples of companies in France at that time and the rest was only academic manufacturing and use.”
Read the full interview here
““We really want to become big in this field – at the moment we are kind of alone but I think that will not be so for long because I think that the NETSPOT/SomaKit TOC and Lutathera example will be enlightening for many people.”
Let’s hope so.
Thanks for reading
Hey, I’m also active on Facebook. Like my page for even more news.
Welcome to my sixth ‘Community’ newsletter. This is April 2017’s monthly summary of Ronny Allan’s Community news, views and ICYMI (in case you missed it!).
There are two main highlights for April which stood out for me:
April was a slower month in ‘new’ blogging terms due to a number of external projects and a continuing flow of private messages. Not forgetting two weeks of lower back pain (don’t forget, I’m a patient too!).
I don’t have an issue with private contact but please note my disclaimer. However, despite a low number of brand new blogs, I still managed to accumulate the biggest monthly blog views ever. ……..Thank you all so much ♥
Due to the vagaries of Facebook inner workings, some of these may not have even shown on your Facebook timeline. So, ICYMI …….here’s a summary with links:
- The trouble with the NET (Part 3) April 27, 2017. Fed up of those ‘miracle cures’ and dodgy headlines?
- Diagnosed with Neuroendocrine Cancer? 10 questions to ask your doctor April 25, 2017. Really good viewing figures and feedback received on this one.
- I’m now a poet 🙂 check out my “Ode to Lanreotide”
- New NET Cancer Grades to be introduced. Check out this updated post with advance notice of what’s coming.
- Poker Face or Cancer Card. Some of the challenges facing life with incurable cancer
- Don’t believe the hype – 10 Neuroendocrine Cancer Myths debunked April 6, 2017. Really good viewing figures and feedback received on this one. Fed up of reading things which you know are wrong?
- There’s no such thing as a ‘tickbox’ Neuroendocrine Cancer patient April 4, 2017. There isn’t!
- Man versus mountain. I set myself a physical challenge on April 2, 2017 by walking up the biggest hill in southern UK. ‘Brain Medicine’ for me!
- NETwork with Ronny © – Newsletter March 2017 April 1, 2017. ICYMI
New Audiences for NET Cancer. From Day 1, I said it was my aim to find new audiences for NETS rather than just share stuff within our own community.
Patients Included. A new campaign for 2017. I was excited to have been invited to the first ever joint Patient-Physician symposium at the annual ENETS conference in Barcelona 8 – 11 March. I have really good information which will feed into my blogs, either as updates or new blogs. This new blog is a result of attending this symposium but it’s from an existing campaign run along the ‘Consequences’ campaign run by Macmillan Cancer Support for all cancers. In the war on Neuroendocrine Cancer, let’s not forget to win the battle for better quality of life
Blog Milestone. In Apr, I tipped over 275,000 views! Thank you all so much ♥ Keep sharing!
Facebook Milestone. I’m aiming for 5000 by year-end and this is on track. The Facebook page is now my biggest outlet for awareness and education so please please please recommend this page to anyone you think would be interested.
I’m expanding into Instagram to see how that goes. I’ve amassed over 200 followers to date. Initially, I’ll just be posting pictures of things that inspire me, mostly scenic photos of places I’ve been or want to go! You can follow me here: Click here to go to my Instagram page
Where did Apr 2017 Blog views come from? – Top 11 countries: Large increase from Germany.
For interest. the 10 Ten Facebook followers by Country – Germany now appears!
WOW! – that’s an amazing amount of awareness and hopefully, support for others. However, I cannot do this without you guys liking, commenting and sharing! The likes give me motivation, the comments (and private messages) give me inspiration (or at least a chance to explain further) and the sharing gives me a bigger platform. A bigger platform generates more awareness.
Thanks for your great support in April. Onwards and upwards!
Thanks for reading
Hey, I’m also active on Facebook. Like my page for even more news.