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Genmab — Maj 2020

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • M Offline
    M Offline
    Mcjean
    wrote on sidst redigeret af
    #71

    yep

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    • K Offline
      K Offline
      KWC
      wrote on sidst redigeret af
      #72

      Genmab Announces U.S. FDA Approval of Subcutaneous Formulation of Daratumumab, DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), for the Treatment of Patients with Multiple Myeloma
      Company Announcement

      Subcutaneous formulation of daratumumab, DARZALEX FASPRO™, approved by the U.S. FDA for the treatment of patients with multiple myeloma
      Approval based on data from Phase III COLUMBA and Phase II PLEIADES studies
      In the studies, the fixed-dose subcutaneous formulation reduced treatment time

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      • G Offline
        G Offline
        GeorgeBest
        wrote on sidst redigeret af
        #73

        https://ir.genmab.com/news-releases/news-release-details/genmab-announces-us-fda-approval-subcutaneous-formulation

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        • PederTP Offline
          PederTP Offline
          PederT
          wrote on sidst redigeret af
          #74

          Sådan ????

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          • PederTP Offline
            PederTP Offline
            PederT
            wrote on sidst redigeret af
            #75

            Chatten er åbenbart ikke optimeret til til emojis 😉 Fedt med den nyhed en fredag aften. Cheers to that!

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            • BudweisB Offline
              BudweisB Offline
              Budweis
              wrote on sidst redigeret af
              #76

              Bingo!

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              • BulderB Offline
                BulderB Offline
                Bulder
                wrote on sidst redigeret af
                #77

                Godkendelsen er specifik. Alcyone, Maia, Castor og Pollux samt monoterapi. Dvs i princippet ikke gældende i transplant-setting: Griffin.

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                • O Offline
                  O Offline
                  OHW
                  wrote on sidst redigeret af
                  #78

                  Ikke den store reaktion i US. Kun delvis godkendelse?

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                  • BulderB Offline
                    BulderB Offline
                    Bulder
                    wrote on sidst redigeret af
                    #79

                    Delvis og delvis. Godkendelsen dækker de felter, hvor dara i forvejen er godkendt. Men der skal måske en ny ansøgning til for at få den godkendt i DRVd-kombinationen (asct-setting).

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                    • BulderB Offline
                      BulderB Offline
                      Bulder
                      wrote on sidst redigeret af
                      #80

                      Som jeg læser det dækker godkendelsen også dara-pom-dex i 3. linje.

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                      0
                      • BulderB Offline
                        BulderB Offline
                        Bulder
                        wrote on sidst redigeret af
                        #81

                        Formuleringen, "patients with relapsed or refractory multiple myeloma who have received at least one prior therapy", rummer både Pollux og dara-pom-dex.

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                        • BulderB Offline
                          BulderB Offline
                          Bulder
                          wrote on sidst redigeret af
                          #82

                          Formuleringen "in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy" går specifikt på Castor.

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                          • troldmandenT Offline
                            troldmandenT Offline
                            troldmanden
                            wrote on sidst redigeret af
                            #83

                            skøn fredag. Men lidt som ventet ikke den store reaktion da det netop vr ventet. Læser jeg det rigtigt at det så ikke er 1. line

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                            • V Offline
                              V Offline
                              Vitus
                              wrote on sidst redigeret af
                              #84

                              Pensionisten: Du skal da ha en ny IPad 🙂

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                              0
                              • SolsenS Offline
                                SolsenS Offline
                                Solsen
                                wrote on sidst redigeret af
                                #85

                                Tillykke med sc approval

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                                0
                                • V Offline
                                  V Offline
                                  Vitus
                                  wrote on sidst redigeret af
                                  #86

                                  Nå for Søren...ja så er der noget andet galt 🙂

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                                  0
                                  • Helge_LarsenPI-redaktørH Offline
                                    Helge_LarsenPI-redaktørH Offline
                                    Helge_LarsenPI-redaktør
                                    wrote on sidst redigeret af
                                    #87

                                    🙂

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                                    0
                                    • G Offline
                                      G Offline
                                      GeorgeBest
                                      wrote on sidst redigeret af
                                      #88

                                      Trolmanden: 1 linie er med

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                                      • V Offline
                                        V Offline
                                        Vitus
                                        wrote on sidst redigeret af
                                        #89

                                        Men til noget helt andet.....reder moneter i det er ? 🙂

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                                        0
                                        • V Offline
                                          V Offline
                                          Vitus
                                          wrote on sidst redigeret af
                                          #90

                                          Åbenbart også noget galt med min IPad....

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                                          0

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