Genmab — Januar 2018
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Det bliver da ret svært at leake info om dara i solide, når grundlaget for sammenligning er en PD1 hæmmer vs. PD1 hæmmer + Dara. Forskellen vil jo forventeligt kun kunne ses i statistikken på response depth, OR og varigheden af response - sammenligning på enkelt eller få pts niveau giver ikke rigtig mening - og dermed ingen leaks, eller???
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God morgen.
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Interview with Orlowski, MD Anderson Cancer Center, early january, don't think it was posted here yet - https://www.myelomacrowd.org/full-show-myelomas-future-in-2018-with-robert-z-orlowski-md-phd-md-anderson-cancer-center/
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when talking about VMP-dara first line, he mentioned " It probably will lead to an FDA approval of daratumumab for this particular patient population who’s not transplant eligible, but it may also allow some of us to use daratumumab up front with other combinations"
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From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient. https://www.fda.gov/ForPatients/Other/OffLabel/ucm20041767.htm
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