Genmab — Oktober 2019

[Parasitism]

god morgen

[E_L]

Dr. Hong on Moving Tisotumab Vedotin to Frontline Therapy for Cervical Cancer
https://www.youtube.com/watch?v=SXX_5UNpkak

[Bulder]

Promising - "good chance".

[E_L]

CHMP:
The Committee recommended extensions of indication for Darzalex, - so i guess that will be officially approved somewhere next month or so. https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-14-17-october-2019

[Bulder]

So it was Maia, that was recommended. I guess we'll get some message from Genmab later today.

[GeorgeBest]

Genmab message https://ir.genmab.com/news-releases/news-release-details/chmp-issues-positive-opinion-recommending-darzalexr-2

[Doublo]

EL den er lige kommet officielt

[E_L]

hmmm. VTd was also on the agenda, was that not recommended then...?

[BENTBOSS]

NYT:GENMAB: EMA-UDVALG UDTALER SIG POSITIVT OM DARZALEX-KOMBINATION

13:19
(Opdateres)

CHMP, der er et udvalg under de europæiske sundhedsmyndigheder, EMA, anbefaler, at Genmabs kræftmiddel Darzalex kan blive brugt i kombination med kræftmidlet Revlimid og Dexamethasone til behandling af knoglemarvskræft.

Det fremgår af en fondsbørsmeddelelse fra selskabet fredag middag.

/ritzau/FINANS

Nicoline Lärka Sørensen
RITZAU

[Helge_LarsenPI-redaktør]

[Helge_LarsenPI-redaktør]

https://ir.genmab.com/news-releases/news-release-details/chmp-issues-positive-opinion-recommending-darzalexr-2

[Helge_LarsenPI-redaktør]

Går der ikke et par måneder efter anbfalingen før en eventuel endelig godkendelse udmeldes?

[Bulder]

60 dage mener jeg

[Helge_LarsenPI-redaktør]

Det bliver til jul.

[Bulder]

Men det er jo ikke en "europæisk" kombination. Ville have været mere relevant med Cassiopeia. Alcyone er i forvejen godkendt. Cassiopeia blev indsendt til EMA 27/3 i år.

[E_L]

it was on the agenda and it went through PRAC earlier this month, so don't know why it didnt get recommended. Unfortunately it takes a few months before we will see the full minutes of the meeting...

[Bulder]

We've seen that before, that even if it's on the agenda, they don't nescesssarily reach a conclusion.

[Bulder]

There was no negative opinion either, so next time.

[E_L]

no , you are correct, there wasn't. hopefully next month then.

[E_L]

i think they stopped recruiting Cassiopeia summer last year already, so i bet there are a lot of transplant eligible patients waiting to get on this
...