Home » Living with Neuroendocrine Cancer » Waiting on Lu-177 PRRT? ….. there’s light at the end of the tunnel

Waiting on Lu-177 PRRT? ….. there’s light at the end of the tunnel


The Hadron Collider – particle accelerator tunnel – there’s a connection to PRRT

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 24 Sep 2017.  More to follow when known.  This is a blow for patients in England.  Read more 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. 

Europe/UK

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”.  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 contraversial 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.

USA

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

The situation is confusing because the therapy has been in use for some time, hasn’t it?

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.

Terminology

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.

NETs leading the way

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.

Advanced Accelerator Applications (AAA) – from Hadron Collider to Neuroendocrine Tumors

Fusing nuclear medicine and a theragnostic approach – the firm that’s ‘alone in the field’ but expecting company

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

Ronny

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11 Comments

  1. Oryx says:

    I was diagnosed with Neuroendicrine cancer in May 2015. I was then treated with Sandostatin LAR every 4 weeks but the cancer kept on spreading. I had my second Lutathera treatment last week. The PET-scan, however, showed that the tumors “looks slightly more intense but with no significant increase in size.” Is this normal? What is the maximum number of treatments that can be done safely? My white cell- and blood platelet count is very low.


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    • Ronny Allan says:

      As I understand it, the max Lutathera (PRRT) is 4. However, i know people in Europe who have done more including a lady on 11! Personalised dosing is being looked at and is already in place in certain European centres. I have no idea what they mean by ‘intense’, perhaps ‘hypervascular’. As for white cell and platelets, unsure of this, better to ask your doctors. Good luck for your treatment.

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  2. My Oncologist counsels to forget PRRT as long as Octreotide works. i feel fine and liver tumors are even shrinking. My only concern is that if Octreotide and PRRT target the same receptors then when/if Octreotide stops working, PRRT potential success will also decline.


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    • Ronny Allan says:

      In UK you won’t get it unless you other treatment isn’t working or tumors are progressing. Some people are suggesting it could be a first line treatment. I suspect private providers might hope so he said cynically 😃 I’m with you, I hope it’s there when I actually need it

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  3. Desi says:

    Thank you, Ronny, as always.
    I travel to Singapore for PRRT and the PET dotascan. I’m grateful it is only around 3 hours away by airplane from my country. For now, only one hospital there does PRRT, but by the latter part of the year, another hospital will have it as well.
    I’ve had 1 session so far. Do any of you know if it’s too early to tell through a PET dota or some other scan if PRRT is actually working for me? I have PNET Glucagonoma with liver mets. Thanks.


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  4. edebock says:

    I had my 8th Lutetium (Lutathera) treatment last week. It has been available in Canada since 2010, though only used in two locations that I know of. I am fortunate to live a 2 hour drive from one of them. I’m waiting for the results of the latest post-treatment scan, but up to this point, there there has been no spread of disease since diagnosis and my existing tumours have been shrinking. I feel 100% well and I’m able to lead a pretty normal life. It frustrates me that this treatment isn’t readily available to NETS patients everywhere.


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    • Josh M says:

      Lutathera – is a brand name of Lu177 Dotatate – NETSPOT and Somakit are brand names as well. NETSPOT and SOMAKIT are different drugs (one is Dotatate and one is dotatoc) Other companies make other version of PRRT drugs (Lutate for instance)

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    • Simon Pedro Arroyo says:

      Hello hi i would love to hear your results with this treatment i live in usa and it is really frustrating that this is not available here, if it works i might as well travel to Canada to get this treatment i have the same disease now im doing fine with the sandostatin every four weeks but is just to control the symptoms so if you don’t mind please let us know if this worked for you, thank you and good luck…

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      • edebock says:

        I’ll have my next CT scan on August 30 and as long as that goes well, another treatment around the beginning of November. By all means, check my blog for updates around those dates. If there’s any other information I can help you with, please let me know!

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