Genmab — Juli 2014
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Det er jo i princippet nogenlunde samme studie som Ibrutinib kørte (resonate) - blot at Gilead satser på Idelalisib i kombi med Ofatumumab fremfor alene. Det er jo i fin tråd med, at ibrutinib umiddelbart har vist stærkere data alene end Idelalisib - og at prækliniske data viser, at Idelalisib har mere glæde af kombination med et CD20 antistof en Ibrutinib har ?
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Tror også man som udgangspunkt skal holde forventningerne nede til Arzerra, men kommer den rigtige partner ind og vil bruge penge på skidtet, så kan det kaste gode royalties af til Genmab. GSK er bare ikke den rigtige partner - og så må vi håbe at Novartis er det eller evt. Gilead vil være med på den ene eller anden måde
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Solsen Gilead har ansøgt så vidt jeg ved
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ja det er second line. samme indikation som idelalisib+ofa phase III køres i
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Solsen se nu mit link. Der står da direkte at de har sendt NDA for Idelalisib + Rituxan i Relapsed CLL patients ?
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the
company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of
idelalisib, an investigational, targeted, oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin’s lymphoma (iNHL).
The data submitted in this NDA support the use of idelalisib for patients with iNHL that is refractory (non-responsive) to rituximab
and to alkylating-agent-containing chemotherapy. -
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