Genmab — Juli 2014

[fillipa]

Enig

[Solsen]

Jeg er egentlig ikke bange for Gazyva idet kapløbet pt er ikke er i mono - Idelalisib/Ibrutinib har sat barren højere således, at CD20 stofferne ikke er med mere i mono. Ret beset må Arzerra være et bedre antistof end Gazyva i kombi.

[Solsen]

Men den kommercielle del skal GSK/Genmab også kunne håndtere.

[investor1989]

Solsen Gilead har ansøgt så vidt jeg ved

[investor1989]

Error

(www.gilead.com)

[Solsen]

2. Line cll ?

[Solsen]

http://track.adform.net/C/?bn=4058859;bsqno=1;li=1;cset=15|15|0|950|200|32|8|0|0|3|7|0|0;js=1;smid=-1;rtbwp=B84194BEDA9A063D;rtbdata=aiWlOcYjps745ifqCiH9lWFKKLUC6hR2bln9pOFu6peMlAlGtfoXxk462I83dV3UlI6DugixPxbF_NdhPGsYfYhjwCgXVj2YhMzF4CBlJzGJQyDp-KM5X6IRuqmvn94-qaxvbhgZ-M3ebcjdBpq-djzQ--ivZSeSHRjJTrfVP1bcPpcqEUKMa94-ZTgKShJCFCyCxGswq31Xl6Ema62yTWSYIWd8AiA36XsBuBhz86roHVWr6prx_YHmCl0hXqycwIQsKSCO-RaGfwUm6Z5dORY2QPyEYtG2gkHCbdOHNLSOqTIb356uIFSZBFnOC1s2CmmYnItHfc6S1v8KP5ai5Wk

[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]

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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