Genmab — Oktober 2019
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Dr. Hong on Moving Tisotumab Vedotin to Frontline Therapy for Cervical Cancer
https://www.youtube.com/watch?v=SXX_5UNpkak -
CHMP:
The Committee recommended extensions of indication for Darzalex, - so i guess that will be officially approved somewhere next month or so. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2019 -
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NYT:GENMAB: EMA-UDVALG UDTALER SIG POSITIVT OM DARZALEX-KOMBINATION
13:19
(Opdateres)CHMP, der er et udvalg under de europæiske sundhedsmyndigheder, EMA, anbefaler, at Genmabs kræftmiddel Darzalex kan blive brugt i kombination med kræftmidlet Revlimid og Dexamethasone til behandling af knoglemarvskræft.
Det fremgår af en fondsbørsmeddelelse fra selskabet fredag middag.
/ritzau/FINANS
Nicoline Lärka Sørensen
RITZAU -

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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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