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Genmab — Marts 2019

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • P Offline
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    Parasitism
    wrote on sidst redigeret af
    #985

    God morgen 🙂

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    • E Offline
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      E_L
      wrote on sidst redigeret af
      #986

      from recent Conference, Tisotumab vedotin
      https://www.mdedge.com/hematology-oncology/article/197472/gynecologic-cancer/tisotumab-vedotin-shows-promise-recurrent

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      • P Offline
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        polle1
        wrote on sidst redigeret af
        #987

        Godmorgen og god dag

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        • B Offline
          B Offline
          bibob
          wrote on sidst redigeret af
          #988

          @pensionisten. Jeg håber at din kone må få nye og bedre behandlingsmuligheder. Der kommer heldigvis nye og forhåbentlig bedre medicin på markedet. Held og lykke. 🙂

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          • J Offline
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            JKY_VH
            wrote on sidst redigeret af
            #989

            Også H&L herfra og god morgen:-)

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            • BulderB Offline
              BulderB Offline
              Bulder
              wrote on sidst redigeret af
              #990

              8:28: det var så lidt. og held og lykke

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              • E Offline
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                E_L
                wrote on sidst redigeret af
                #991

                and europe
                https://www.globenewswire.com/news-release/2019/03/27/1773690/0/en/Genmab-Announces-European-Regulatory-Submission-for-Daratumumab-in-Combination-with-Bortezomib-Thalidomide-and-Dexamethasone-in-Frontline-Multiple-Myeloma.html?culture=fr-ca

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                • E Offline
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                  E_L
                  wrote on sidst redigeret af
                  #992

                  they are on a roll!

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                  • S Offline
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                    Sukkeralf
                    wrote on sidst redigeret af
                    #993

                    Nu nærmer ASCO sig snart - ikke at det bliver den vigtigste konference for Genmab, men om ikke andet kommer der vel opdateringer på diverse dara-studier. Abstract deadlines:

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                    • S Offline
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                      Sukkeralf
                      wrote on sidst redigeret af
                      #994

                      ASCO Meetings

                      ASCO Meetings Program Guide

                      favicon

                      (meetings.asco.org)

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                      • S Offline
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                        Sukkeralf
                        wrote on sidst redigeret af
                        #995

                        Nice E L - did we get 100% sure on filing for sc dosing. Was the Columba data enough or.......?

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                          E_L
                          wrote on sidst redigeret af
                          #996

                          that's the million dollar question @Sukkeralf … well more like billion dollar question in this case lol

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                          • S Offline
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                            Sukkeralf
                            wrote on sidst redigeret af
                            #997

                            Bulders question: Can data from the Columba study be the basis for approval in all treatment lines in MM, or do we have to await the sc combo study MMY2040?

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                            • B Offline
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                              bibob
                              wrote on sidst redigeret af
                              #998

                              https://ir.genmab.com/news-releases/news-release-details/genmab-announces-european-regulatory-submission-daratumumab-3

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                                Sukkeralf
                                wrote on sidst redigeret af
                                #999

                                jans answer: The COLUMBA study is the only non inferiority PHIII that would be needed to obtain a label for SC daratumumab...

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                                  Sukkeralf
                                  wrote on sidst redigeret af
                                  #1000

                                  In order to obtain a broader label, we would also need to obtain safety data from the PLEIADES study which is evaluating 3 cohorts of patients DARA + RD, DARA + VMP and DARA + VRD. If this study reads out positively, we expect to obtain a broad label for SC DARA..

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                                  • S Offline
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                                    Sukkeralf
                                    wrote on sidst redigeret af
                                    #1001

                                    To me thats sounds like they will file first on the Columba data............and then later a sBLA on combination data

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                                      E_L
                                      wrote on sidst redigeret af
                                      #1002

                                      that is also my best geuss at the moment

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                                      • BulderB Offline
                                        BulderB Offline
                                        Bulder
                                        wrote on sidst redigeret af
                                        #1003

                                        Yes,and with a label limited to R/R MM and not frontline.

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                                        • S Offline
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                                          Sukkeralf
                                          wrote on sidst redigeret af
                                          #1004

                                          yes and maybe maintenance

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