Er der påbegyndt fase 3 frontline studier i cll i januar 2009?? var det ikke second line?
CLL Filed
Jan 2009 Ph III
Filed in USA for refractory CLL on
30th Jan 2009
Phase III front-line CLL study
started in Jan 2009.
NHL Ph III Ph III
ofatumumab
RA Ph III Ph III
Deliver more products of value
We currently have more than ten key new products filed with regulators in the USA, Europe
and Japan, including two innovative oncology products: ofatumumab, filed last week and
pazopanib, which we announced today.
These two assets will be clear examples of what I mean by delivering more products of value.
We expect they will offer meaningful improvements to patients in both tolerability and efficacy
and we are committed to ensuring that we listen to payers to ensure that these medicines are
successfully reimbursed.
We currently have more than ten key new products filed with regulators in the USA, Europe
and Japan, including two innovative oncology products: ofatumumab, filed last week and
pazopanib, which we announced today.
These two assets will be clear examples of what I mean by delivering more products of value.
We expect they will offer meaningful improvements to patients in both tolerability and efficacy
and we are committed to ensuring that we listen to payers to ensure that these medicines are
successfully reimbursed.
5/2 2009 15:38 Solsen 0
2083 Det håber vi så at de sikrer.
Så kommer de første milestones snart på de nyigangsatte forsøg.
EMEA også lige om hjørnet.
Mon ikke de 250 snart står for fald ?
Så kommer de første milestones snart på de nyigangsatte forsøg.
EMEA også lige om hjørnet.
Mon ikke de 250 snart står for fald ?
hvad siger du til first line forsøget i januar er det rigtigt? Var det ikke 2nd line?
5/2 2009 15:58 Solsen 02090 Potential to Combat CLL in Earlier Stages
The companies also announced today the initiation of an additional Phase III study of ofatumumab in combination with fludarabine and cyclophosphamide (FC) for patients with CLL when initial treatment no longer works (second-line treatment). The open-label study will randomize 352 patients to evaluate progression-free survival (PFS) of ofatumumab in combination with FC therapy versus FC therapy alone for the treatment of relapsed CLL.(7) Enrollment for this study will begin shortly.
"Bolstered by the positive results of ofatumumab for advanced stage CLL, we're now investigating ofatumumab in earlier stages in the treatment continuum," said Paolo Paoletti, M.D., Senior Vice President of Oncology R&D, GSK. "The clues we're seeing from ofatumumab also suggest possible activity in other oncology settings, which we're currently evaluating through several clinical trials."
GSK and Genmab will conduct additional studies of ofatumumab in CLL and non-Hodgkin's lymphoma (NHL) settings. In CLL, a Phase III front-line study is evaluating ofatumumab combined with chlorambucil in patients with previously untreated CLL. In NHL, an ongoing Phase II study will assess ofatumumab in patients with Waldenstrom's Macroglobulinemia - a rare type of slow-growing NHL.(8) Finally, a Phase II study is evaluating ofatumumab plus ICE or DHAP chemotherapy regimen in relapsed/ refractory diffuse large B cell lymphoma (DLBCL).
Lidt forvirrende - de påbegyndte et fase 3 i second line jf ovenstående meddlelse i januar 2009. Det i sidste afsnit omtalte fase 3 forsøg er ongoing
http://clinicaltrials.gov/ct2/show/NCT00748189?term=ofatumumab&rank=7
The companies also announced today the initiation of an additional Phase III study of ofatumumab in combination with fludarabine and cyclophosphamide (FC) for patients with CLL when initial treatment no longer works (second-line treatment). The open-label study will randomize 352 patients to evaluate progression-free survival (PFS) of ofatumumab in combination with FC therapy versus FC therapy alone for the treatment of relapsed CLL.(7) Enrollment for this study will begin shortly.
"Bolstered by the positive results of ofatumumab for advanced stage CLL, we're now investigating ofatumumab in earlier stages in the treatment continuum," said Paolo Paoletti, M.D., Senior Vice President of Oncology R&D, GSK. "The clues we're seeing from ofatumumab also suggest possible activity in other oncology settings, which we're currently evaluating through several clinical trials."
GSK and Genmab will conduct additional studies of ofatumumab in CLL and non-Hodgkin's lymphoma (NHL) settings. In CLL, a Phase III front-line study is evaluating ofatumumab combined with chlorambucil in patients with previously untreated CLL. In NHL, an ongoing Phase II study will assess ofatumumab in patients with Waldenstrom's Macroglobulinemia - a rare type of slow-growing NHL.(8) Finally, a Phase II study is evaluating ofatumumab plus ICE or DHAP chemotherapy regimen in relapsed/ refractory diffuse large B cell lymphoma (DLBCL).
Lidt forvirrende - de påbegyndte et fase 3 i second line jf ovenstående meddlelse i januar 2009. Det i sidste afsnit omtalte fase 3 forsøg er ongoing
http://clinicaltrials.gov/ct2/show/NCT00748189?term=ofatumumab&rank=7
ja det mente jeg også. så det er nok en fejl fra Gsk side
5/2 2009 16:11 Solsen 02094 Læg mærke til, at forsøget startede i december 2008 og Genmab har ikke meddelt noget - så GSK kan have ret, hvis de første infusioner var i januar - der burde vel falde en milestone på dette forsøg sammen med secondline forsøget !
jeg må sige at jeg intet fatter. Heller ikke hvor vores milestones er for BLA? De plejer jo at være front end loaded? Skal den virkelig baseres på fda´s accept af ansøgning om en måned? Det er alligevel et stykker vej til en lille milliard kr i preapproval.
5/2 2009 16:16 Solsen 02096 Ro på de kommer i en lind strøm.
Drømmer om at GSK lige nu tæller på knapperne inden milestones falder - skal/skal ikke slå til
Drømmer om at GSK lige nu tæller på knapperne inden milestones falder - skal/skal ikke slå til
5/2 2009 18:03 tumult 02101 Jeg har på fornemmelsen at CBS skal have mange flere, ellers kan jeg ikke se nogen mening med deres handler.
5/2 2009 18:49 tumult 02103 CSB hedder de selvfølgelig. Jeg tror ikke de er færdige, spændende afslutning.
Egentligt ok, når man tænker på markedet generelt. Nu tror jeg at jeg skal have hørt den GSK CC igennem, så kommer jeg med et referat
5/2 2009 19:05 tumult 02106 SUPER så er vi andre fri for det.
CSB blev snyd i sidste øjeblik, da den rykkede i 245,25 et sekund før afslutning.
Det så ud som om de lå med køb på 20.000 stk så mon ikke de skal have dem i morgen.?
CSB blev snyd i sidste øjeblik, da den rykkede i 245,25 et sekund før afslutning.
Det så ud som om de lå med køb på 20.000 stk så mon ikke de skal have dem i morgen.?
5/2 2009 19:19 Stinker 02107 Gid hende der Credit-Sussie bare ville købe Nordea, så vi kunne slippe for deres udsalg.
kom lige ind i slutningen af Q&A. Der blev spurgt til Ofab. De anser den for superior og de går head to head med rituxian. Den er bedre tolereret og det vil blive lægens vurdering om man skal vælge den ene eller den anden. De lød ret faste i kødet.
