Genmab — Marts 2019

[bibob]

@pensionisten. Jeg håber at din kone må få nye og bedre behandlingsmuligheder. Der kommer heldigvis nye og forhåbentlig bedre medicin på markedet. Held og lykke.

[JKY_VH]

Også H&L herfra og god morgen:-)

[Bulder]

8:28: det var så lidt. og held og lykke

[E_L]

and europe
https://www.globenewswire.com/news-release/2019/03/27/1773690/0/en/Genmab-Announces-European-Regulatory-Submission-for-Daratumumab-in-Combination-with-Bortezomib-Thalidomide-and-Dexamethasone-in-Frontline-Multiple-Myeloma.html?culture=fr-ca

[E_L]

they are on a roll!

[Sukkeralf]

Nu nærmer ASCO sig snart - ikke at det bliver den vigtigste konference for Genmab, men om ikke andet kommer der vel opdateringer på diverse dara-studier. Abstract deadlines:

[Sukkeralf]

ASCO Meetings

ASCO Meetings Program Guide

(meetings.asco.org)

[Sukkeralf]

Nice E L - did we get 100% sure on filing for sc dosing. Was the Columba data enough or.......?

[E_L]

that's the million dollar question @Sukkeralf … well more like billion dollar question in this case lol

[Sukkeralf]

Bulders question: Can data from the Columba study be the basis for approval in all treatment lines in MM, or do we have to await the sc combo study MMY2040?

[bibob]

https://ir.genmab.com/news-releases/news-release-details/genmab-announces-european-regulatory-submission-daratumumab-3

[Sukkeralf]

jans answer: The COLUMBA study is the only non inferiority PHIII that would be needed to obtain a label for SC daratumumab...

[Sukkeralf]

In order to obtain a broader label, we would also need to obtain safety data from the PLEIADES study which is evaluating 3 cohorts of patients DARA + RD, DARA + VMP and DARA + VRD. If this study reads out positively, we expect to obtain a broad label for SC DARA..

[Sukkeralf]

To me thats sounds like they will file first on the Columba data............and then later a sBLA on combination data

[E_L]

that is also my best geuss at the moment

[Bulder]

Yes,and with a label limited to R/R MM and not frontline.

[Sukkeralf]

yes and maybe maintenance

[Doc4]

@pensionisten 8:28....FYI Mayzent = Siponimod og er beskrevet her: https://scleroseforeningen.dk/nyheder/gilenya-20. Samme virkning da siponimod er en syntetisk udgave af Gilenya, som har væet på markedet i 7 år. Siponimod har en bedre bivirkningsprofil, da target kun er 2 ud af 5 forskellige SiP molekyler, hvor Gilenya targets 4/5, hvoraf et i hjertet. Held og lykke;)

[Doc4]

Hmm...ser ud til links fungere bedst, som afslutning og uden andre karakterer efterfølgende, så her er link der fårhåbentlig fungerer https://scleroseforeningen.dk/nyheder/gilenya-20

[Vester]

The Plaides study has been fully recruited for approx 5 months now.. One could hope that the label expansion happens fast, as they only need safety data, as Jan states..