Home » Living with Neuroendocrine Cancer » Waiting on PRRT ….. light at the end of the tunnel?

Waiting on PRRT ….. light at the end of the tunnel?

Recent Posts


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

There’s a lot of questions doing the rounds on forums and messages about the approval of Lutathera (PRRT) in USA but I know nothing about an anticipated approval date. Negotiations are still ongoing between US FDA and the Lutathera manufacturer Advanced Accelerator Applications (AAA). A pharmaceutical media outlet today published an interview with the CEO of AAA which has prompted this post. Whilst there is no indication of date mentioned, I’ve placed a link to it the end – it’s more commercial than medical related but some will find it interesting. For those who are not aware, AAA is the manufacturer of diagnostic and therapeutic radionuclide drugs for use in Neuroendocrine Tumors and other cancers.

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.  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. Hopefully it will be reintroduced to England soon. 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!  It really is an international disease! 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.

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.

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
community_titled_transparent_2013-10-22

7 Comments

  1. 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.


    https://polldaddy.com/js/rating/rating.js

    Liked by 1 person

    • 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

      Like

  2. 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.


    https://polldaddy.com/js/rating/rating.js

    Liked by 1 person

  3. 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.


    https://polldaddy.com/js/rating/rating.js

    Liked by 1 person

    • 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)

      Like

Thanks for the comment, make sure you have ticked the box to receive notifications of responses

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s

Blog Stats

  • 291,361 hits

Enter your email address to follow this blog and receive notifications of new posts by email.

Join 8,808 other followers

Recent Posts

%d bloggers like this: