Genmab — Marts 2019
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and it looks like they will give this one another try https://clinicaltrials.gov/ct2/history/NCT03346135?A=5&B=6&C=merged
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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
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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."
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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 -
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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
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God morgen. :-). Ny FDA chef. https://medwatch.dk/Mennesker/article11248423.ece
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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
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