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  • larshansson18 larshansson18 Jan 21, 2010 8:13 AM Flag

    !!Great news: Epicept included in guidelines AML!!

    There is a move south in Sthlm, because of these guidelines. The interpretation from different posts seems to be running in different directions: Those who are content that there is one page where Ceplene is mentioned and another one, stating that the use of Ceplene is more or less restricted to be used in the running phase 4 trial.

    Even if you are Swedish spoken it is hard to interpret the text in just one way. My own interpretation, just reading the text, is that the text signals that there will be new guidlines later, until then the phase 4 trail is the main path. That is, in Sweden.

    "Ingen konfirmerande fas III studie har genomförts, men en fas IV studie ägnad att närmare
    undersöka effekten av IL-2 + histamin på MRD och T-cellsfunktion pågår (2009-2011) i Europa
    och med svenskt deltagande (se sid 3).
    Baserat främst på ovan nämnda fas III studie godkändes Ceplene® våren 2009 av EMEA för
    underhållsbehandling (i kombination med IL-2) av patienter med AML i CR1 inte aktuella för
    allo-SCT. I Sverige är preparatet ännu inte prisförhandlat, men kan för närvarande erhållas
    via läkemedelsföretagets (EpiCept) ”named patient program”.
    Mot bakgrund av ovanstående anser vi att eventuell underhållsbehandling med Ceplene® +
    Proleukin® i första hand bör ske inom ramen för ovan nämnda fas IV studie."

    The translation and interpretation of "i första hand" is of course also crusial. The expression also makes it possible to use outside the ongoing trial before changing the guidelines.

    The next, latest, date for review of these guidelines is in two years: "Gäller fr o m 2010-01-01 Uppdateras senast 2011-12-31"

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    • Thanks you Lars, I was wondering why the sell-off in Sweden...

      • 1 Reply to dknospam
      • The selloff in Sweden was not due to this news, the lows was hit before this news.

        Anyways, i find it interesting that some nimwitt idiot at SiX (newsagency) can make such a bad interpretation of what was noted in the guidelines.
        For me i believe it is very easy to interpret the guidelines.

        It is VERY positive that Ceplene is noted in the guidelines, even thought they were written befor a partnership agreement (this is important to take note off).

        Now to the English/Swedis.
        It is stated "due to whats stated above" (in the previous sentence it is noted that there is no pricing for the product yet but it is available through the named patient program) it is recommended firstly (not primarily thats a different word in swedish) within the Phase IV studies. This could be interpreted as due to the availability/pricing issue it is firstly recomended within the phase iv studies. And i think thats how you should interpret it.

        However you interpret it, i believe it is extremely positive that ceplene is noted in the guidelines and it is also noted that it has significant effect.
        The fact that it is noted in the guidelines will prompt Doctors to inform their patients about this treatment. If i was a patient, i would demand this treatment if i knew about it.

        It is in the section of "new treatments" and it is a guideline, not a sales-brochure, so i don't know what wording people do expect, but if you can interpret anything like bad news that seems to be the way with epicept. Several proffesional bashers in Sweden engaged in this so i am not suprised...

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