Genmab — Oktober 2015
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Ved ikke om International Myeloma Workshop i Rom har været diskuteret. Novod deltog og skriver meget positivt derfra, bl.a: ”the workshop clearly underscored that the approval of Dara is eagerly awaited, and that awareness is spreading beyond KOLs” – og ”A key driver of the enthusiasm about Dara is the hope that monoclonal anti-bodies will be a widely applicable “backbone” treatment similar to Rituximab in lymphoma, and J&J’s extensive development programme for Dara is clearly aimed at this"
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Han skriver også at ”the workshop provided confidence on Dara’s potential in smouldering myeloma” samt ”No trial data is yet available, but first patients have just been dosed this summer. We discussed the trial with one of the investigators, who believed that Dara is the most attractive treatment option in high-risk smouldering myeloma”
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Nice - skriver han noget med, hvornår/om vi kan forvente interim data?
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Primary outcomes i smoldering studiet er CR og "events" - mon ikke der er bygget nogle foreløbige analysepunkter ind i protokollen?
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og studiet er "kun" på 120 patienter - kan det danne basis for godkendelse?
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Det er lige det - smoldering har noget lange udsigter, som det ser ud lige nu
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ja, hvis man skal være direkte brutal, så er smoldering måske endda en ulempe for GEN, da patienterne så er længere tid om at nå til traditionel 1,2,3 linie behandling...
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...eller ligefrem ikke når dertil!
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