Genmab — Juli 2014

[Solsen]

Dette forsøg med Rituxan er der ikke søgt på ?

[investor1989]

ja det er second line. samme indikation som idelalisib+ofa phase III køres i

[Solsen]

...og de har ikke ansøgt om approval. Så alt andet lige må de jo afvente ofa "armen"

[investor1989]

Solsen se nu mit link. Der står da direkte at de har sendt NDA for Idelalisib + Rituxan i Relapsed CLL patients ?

[gentogen]

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.

[gentogen]

Content not found

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(www.terrapinn.com)

[gentogen]

Opdateret http://clinicaltrials.gov/ct2/show/NCT00574288?term=daratumumab&rank=8&submit_fld_opt=

[investor1989]

tak for det gentogen

[investor1989]

Var sikker på at det var Rituxan+Idealisib men kan godt læse nu at det ser ud til at være idelalisib i mono

[investor1989]

Det er vel fordi det er færdigrekruteret det data studie?

[investor1989]

Har lige tjekket, de trak også 35% der

[Sukkeralf]

Angående Idelalisib + rituxan, så skriver de her at:

[Sukkeralf]

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

[Sukkeralf]

Error

(www.gilead.com)

[Sukkeralf]

Gilead is now engaging in a dialogue with the FDA regarding a regulatory filing in CLL. Gilead filed for approval in iNHL and CLL with the European Medicines Agency (EMA) on October 28, 2013.

[Sukkeralf]

Desuden bliver det spændende at følge deres Syk inhibitor GS-9973 - den kombineres også med Idelalisib, så de får en ren oral behandling !

[Sukkeralf]

Kan ikke lige huske om de også kører kombi forsøg med den og CD20 antistoffer

[Sukkeralf]

Checkede lige og det gør Gilead ikke, men der er heller ikke kørt så mange kliniske studie endnu, så det kan være det kommer

[Solsen]

Jeg mener, at huske at de har problemer med deres syk-inhibitor - tumour lysis syndrome (TLS).

[Sukkeralf]

Det er muligt Solsen - har ikke fuldt med !