Genmab — Oktober 2018
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whilst you are talking about MRD ; FDA working on that , Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment, which the FDA is developing to assist sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials of drugs or biologics to treat specific blood cancers. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm623411.htm
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MRD er forresten allerede indført til det kommende: https://clinicaltrials.gov/ct2/show/NCT03652064?term=daratumumab&phase=2&rank=4
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Jeg har et spørgsmål angående SC dara istedet for IV dara. Når nu SC bliver godkendt i forsøget, hvor de sammenlignes. Skal SC så godkendes igen i alle de allerede godkendte kombinationer, eller kan man direkte gå fra IV til SC uden det store bøvl?
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Thestrup: Winkel svarede på det på en tidligere Q&A: Spm.: In january you started a “Study to evaluate Subcutaneous Daratumumab in
combination with Standard Multiple Myeloma Treatment Regimens”, which is a Phase
2. You already have the Phase 3 SC vs IV study; could these 2 clinical trials be the
basis for an overall approval of SC in all lines and settings? Svar: This is a good thought.
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