Home » Living with Neuroendocrine Cancer » Telotristat Ethyl – an oral treatment for Carcinoid Syndrome

Telotristat Ethyl – an oral treatment for Carcinoid Syndrome

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Telotristat Ethyl is an extremely significant introduction to the treatment of Carcinoid Syndrome as it would be the first addition to the standard of care in more than 16 years and the first time an oral syndrome treatment has been developed.  The drug was previously known as Telotristat Etiprate but was changed to Ethyl in Oct 2016. Etiprate was previously a truncation of ethyl hippurate.  

Who is the drug for?

The drug may be of benefit to those whose carcinoid syndrome is not adequately controlled by somatostatin analogues (Octreotide/Lanreotide). It doesn’t replace somatostatin analogues – it is an additional treatment.

When is it due in service?

The US FDA’s decision to approve the drug is anticipated by 28 February 2017 (previously 30 November 2016). The European Medicines Agency has also accepted the filing for Telotristat Ethyl as an adjunct (i.e. in addition) to somatostatin analogue therapy for the long-term treatment of carcinoid syndrome.

In addition to the European submission, Ipsen will pursue a worldwide regulatory plan for marketing authorisation submissions in the territories in which it operates.  Once approved, Ipsen will be distributing the drug in all countries less USA and Japan where Lexicon retains the rights. The approval estimate outside USA is not yet clear but my best guess is that the EMA approval should be later in 2017 after the US FDA approval and then subject to local regulations for achess to treatment and reimbursement. Outside USA and Europe will be constrained by national approval timelines.

How does it work?

In the simplest of terms, the drug is an inhibitor of the enzyme tryptophan hydroxylase (TPH).  TPH is the rate-limiting enzyme in serotonin synthesis which converts tryptophan (an essential amino acid which comes from diet) to 5-hydroxytryptophan, which is subsequently converted to serotonin, one of the main causes of carcinoid syndrome effects including carcinoid heart disease.  The trial data indicates that Telotristat ethyl significantly reduced the frequency of bowel movements. Furthermore it was also associated with “significantly reduced levels of urinary 5-HIAA“, a marker for systemic serotonin levels, which are typically elevated in severe carcinoid syndrome.

Resources for your perusal:

  • You can read more about the trial data in a summary by Dr Matthew Kulke (Dana Farber) by CLICKING HERE (latest review from 2017 ASCO).
  • There is also an excellent summary in video form by Dr Lowell Anthony (University of Kentucky) by CLICKING HERE. (“any reduction in diarrhea is meaningful“).
  • The 2016 ENETS conference also indicated a knock on effect of reducing the risk of, and perhaps even halting Carcinoid Heart Disease.  You can read about this by CLICKING HERE.
  • An excellent technical description of the drug can be found by CLICKING HERE.
  • The detailed output from the trial (results) can be found by CLICKING HERE.
  • Great 2016 article from ASCO (American Society of Clinical Oncologists) can be found by CLICKING HERE.

I know some patients who participated in the trial and they seem to be positive about the drug – if anyone can make a comment, that might be helpful to others who are thinking this new drug might be useful for them when it becomes available.

Thanks for reading

Ronny Allan

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16 Comments

  1. Ronny, keep up your fantastic work! You are my only reliable and comprehensive source of information, Thank you!

    Liked by 1 person

  2. edebock says:

    This is indeed good news! Thank you for keeping us informed, Ronny.

    Liked by 1 person

  3. MÁRCIA says:

    Thanks for information!! This is a very good News. I think I will need it.

    Liked by 1 person

  4. Mary A. Edwards says:

    Ronny, Excellent blog, as always! I am one of the Telotristat clinical trial patients, been taking it since November 2014 – 17 months now. It has made a major difference in the quality of my life. I have very few bouts of diarrhea, maybe 2 or 3 per month versus 12 or more per day! Flushing disappeared. Heart remains healthy. I still get abdominal pain – no differences there. But the freedom to plan and live my life and not worry about where bathrooms are is such a blessing. I hope this drug gets through the FDA hurdles and the regulatory agencies of all other countries very fast so that all carcinoid syndrome patients can have access to it. And I hope the manufacture does not get greedy with the pricing and that all the drug insurance plans cover it adequately.

    Liked by 1 person

  5. I’ve been talking telotristat since July 2013. I cannot imagine my life without it, so I sure hope my insurance will cover it reasonably once it goes to market and is no longer free to me!! I take both Telotristat and somatostatin analogues. My symptom control isn’t as great has what Mary Edwards has posted hers is, but believe me it made a major improvement in my quality of life. As well as reducing diarrhea & flushing, it seems to have cleared up foggy brain, reduced anxiety and other symptoms that aren’t normally mentioned as syndrome symptoms. It helped me so much, that when I had a kidney stone that didn’t want to pass, I told my urologist I would risk kidney damage waiting on it before I’d let him do surgery and get me kicked out of the trial! (That was in the early stage of the trial during a period I couldn’t have surgery and stay in the trial.) If I have any side effect from the medication, it might be a sensitivity to heat that I had never had before. Of course, that could be age related, (as I’ve never been this old before!) or disease related, and not a side effect.

    Liked by 1 person

  6. Ronny Allan says:

    Good update Rosie, I suspect people will be interested.

    Like

  7. Mariana Andreotti Dias says:

    Parabens! Obrigada pelos esclarecimentos!!!

    Liked by 1 person

  8. tensnut says:

    Ronny, nice blog! Do you know if there have been observational side effects of reducing tumor growth, like is seen with SSA’s?

    Liked by 1 person

    • Ronny Allan says:

      Good question. I don’t see how there can be as it’s not that type of drug. It works by reducing the manufacture of serotonin from tryptophan. I just scanned the trial data output (it’s the last link in the blog text) but nothing relevant. To be honest, if there was any evidence of an anti-tumor effect, the manufacturers would be all over that like a rash!

      Like

  9. Areen Al Feelat says:

    Hi Ronny

    I would like to ask if the drug is avaliable in the drug market or from where we can get it ?

    Like

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