Genmab — Marts 2019

[E_L]

great. let's hope european application can follow soon so we can get to the transplant eligible patients

[transalp]

Go morgen..

[Bulder]

Novatis Mayzent : https://www.reuters.com/article/us-fda-mayzent/novartis-gets-u-s-approval-for-new-drug-to-treat-multiple-sclerosis-idUSKCN1R8019

[Bulder]

Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease

Novartis (www.novartis.com)

[bibob]

Også Celgene i MS. Der er kamp om det. https://m.firstwordpharma.com/hot-heels-eu-application-celgene-files-us-clearance-ozanimod-relapsing-multiple-sclerosis

[Parasitism]

God morgen

[E_L]

from recent Conference, Tisotumab vedotin
https://www.mdedge.com/hematology-oncology/article/197472/gynecologic-cancer/tisotumab-vedotin-shows-promise-recurrent

[polle1]

Godmorgen og god dag

[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...