Genmab — Marts 2019
-
and the Tisotumab Vedotin safety study published the results
https://clinicaltrials.gov/ct2/history/NCT02552121?A=10&B=11&C=merged -
well , at least NICE itself also calls daratumumab a “potentially game-changing” treatment https://twitter.com/NICEcomms/status/1105468491388338176
-
They don't believe it has proved to be cost effective yet but : "The patient experts stated that the psychological benefit of delaying a second relapse had not been captured in the quality-of-life measure in the trial. The committee agreed that this had not been captured in the model."
-
Janssen Submits Application to U.S. FDA … Application supported by the Phase 3 MAIA study being reviewed under the FDA Real-Time Oncology Review pilot program
https://www.prnewswire.com/news-releases/janssen-submits-application-to-us-fda-seeking-approval-of-darzalex-daratumumab-combination-therapy-for-patients-with-newly-diagnosed-multiple-myeloma-who-are-transplant-ineligible-300811239.html -
-
So it took 7 weeks from initiation till full dosier. This is precisely according to the plan. From week 9 - 16. But the plan also says that now starts the PDUFA clock. If there is such a clock, I would have expected a PDUFA-date to be published as well.
https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/OCE/ucm612927.htm -
i think the PDUFA date is still +6 months looking at the examples on page 13? https://www.focr.org/sites/default/files/Friends Annual Meeting Panel 3 Slides.pdf
-
God morgen. :-). Ny FDA chef. https://medwatch.dk/Mennesker/article11248423.ece
-
Lige en opfølgning på NICE fra i går. https://m.firstwordpharma.com/uk-myeloma-patients-offered-new-game-changing-option-second-line-treatment-through-cancer-drugs-fund
-
Hello! It looks like you're interested in this conversation, but you don't have an account yet.
Getting fed up of having to scroll through the same posts each visit? When you register for an account, you'll always come back to exactly where you were before, and choose to be notified of new replies (either via email, or push notification). You'll also be able to save bookmarks and upvote posts to show your appreciation to other community members.
With your input, this post could be even better 💗
Tilmeld Log ind