Genmab — Juli 2014
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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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tak for det gentogen
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Var sikker på at det var Rituxan+Idealisib men kan godt læse nu at det ser ud til at være idelalisib i mono
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Det er vel fordi det er færdigrekruteret det data studie?
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Har lige tjekket, de trak også 35% der
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These data in CLL support Gilead’s plans for regulatory filings for idelalisib in the United States and European Union. On September 11, 2013, Gilead submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for idelalisib for the treatment of refractory indolent non-Hodgkin’s lymphoma (iNHL). Following Gilead’s NDA submission for iNHL, FDA granted idelalisib a Breakthrough Therapy designation for CLL in relapsed patients based on results from Study 116. Gilead is now
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