Genmab — Oktober 2019
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Går der ikke et par måneder efter anbfalingen før en eventuel endelig godkendelse udmeldes?
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Det bliver til jul.
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I wonder if they are considering a limitation of the indication. We have this problem with Cassiopeia as well as Griffin, that high risk pts don't really benefit from adding dara. In Cassiopeia they do benefit a little, but that is because VTd is a "weaker" combination. In Griffin HR-pts don't benefit at all, as VRd is a better combination. So for 15% of pts it would be waste of money to add dara.
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i was thinking if there were enough patients in that subgroup HR to make that conclusion, but there are i think, just checked https://multiplemyelomahub.com/medical-information/imw-2019-subgroup-analysis-cassiopeia
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the press release from Janssen https://www.businesswire.com/news/home/20191018005289/en/CHMP-Grants-Positive-Opinion-Expanded-Janssen’s-Darzalex
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And in Griffin as well: Dr. Voorhees noted that D-RVd was favored across all subgroups for MRD negativity and stringent compete response, except among patients with high-risk cytogenetics and stage III disease. https://www.mdedge.com/hematology-oncology/article/208465/multiple-myeloma/combo-could-be-new-standard-transplant-eligible
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