Genmab — Oktober 2019

[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
...

[Bulder]

I wonder if they are considering a limitation of the indication. We have this problem with Cassiopeia as well as Griffin, that high risk pts don't really benefit from adding dara. In Cassiopeia they do benefit a little, but that is because VTd is a "weaker" combination. In Griffin HR-pts don't benefit at all, as VRd is a better combination. So for 15% of pts it would be waste of money to add dara.

[Bulder]

That said, it's still early days with Griffin. It could be better over time. And Griffin is only a small study. Perseus will show us how things really are concerning HR pts.

[E_L]

Are you suggesting JNJ would put a limitation? I doubt they'll do that.... But I agree MD's will be less likely to choose it for HR patients

[Bulder]

Voorhees himself has spoken about it. Be cautious with HR, if you start to use D-VRd now already. No not JnJ. The authorities.

[E_L]

do you think there is enough sub-data for them to do that already?

[Bulder]

For standard-risk, yes. Or what do You mean?

[E_L]

i was thinking if there were enough patients in that subgroup HR to make that conclusion, but there are i think, just checked https://multiplemyelomahub.com/medical-information/imw-2019-subgroup-analysis-cassiopeia

[E_L]

the press release from Janssen https://www.businesswire.com/news/home/20191018005289/en/CHMP-Grants-Positive-Opinion-Expanded-Janssen’s-Darzalex▼