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Endocyte, Inc. (ECYT) Message Board

  • porcupineonweed porcupineonweed Apr 17, 2014 8:55 PM Flag

    THREE Endocyte Medicines Recommended by CHMP!!

    I did not realize that THREE medicines were approved at the CHMP. THREE. The monthly meeting of the CHMP gave positive recommendation for 9 medicines. THREE are Endocytes:


    Go to CHMP webpage and meeting minutes from last week

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    • Por, thanks, good information to have.

    • On 20 March 2014 , the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation 2 for the medicinal product Folcepri intended to be used , after intravenously administered folic acid , in single photon emission computed tomography (SPECT) imaging to select adult patients with ovarian cancer suitable for treatment with the anticancer medicine vintafolide . Folcepri was designated an orphan medicinal product on 10 September 2012 . The applicant for this medicinal product is Endocyte Europe, B.V. Folcepri is to be available as a 100 microgram k it for radiopharmaceutical preparation . The active sub stance of Folcepri , etarfolatide , consist s of folic acid and a technetium - 99m chelating peptide . It bind s to the folate receptor expressed on the surface of many types of cancers, including ovarian cancer. Following radiolabeling with technetium - 99m, Folce pri i s used in SPECT imaging to detect cancer cells with folate receptor . The benefits with Folcepri are its ability to detect adult patients with platinum - resistant ovarian cancer that express the folate receptor on all target lesions and who are therefor e suitable for treatment with vintafolide , which targets cancer cells expressing the folate receptor ( see Summary of Opinion on Vynfinit ) . The only side effect reported with Folcepri was pruritus , which was reported uncommonly . A pharmacovigilanc e plan for Folcepri will be implemented as part of the marketing authorisation. The text for the approved indication is as follows : " This medicinal produ ct is for diagnostic use only. After radiolabelling with sodium pertechnetate ( 99m Tc) solution, Folcepri is indi cated, after intravenously administered folic acid, for single photon emission computed tomography (SPECT) imaging, in combination with Computed Tomography (CT) or Magnetic Resonance Imaging (MRI), for the selection of adult patients for treatment with

 
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