Genmab — Maj 2021

[E_L]

For example, if you look at Main Inclusion Criteria Escalation Part for Epco Ph I/II trial, it says '
Patients must have measurable disease by CT, MRI or PET-CT scan'

[E_L]

In the Ph3 it already says 'Patients must have detectable disease by PET scan and measurable by CT scan or MRI'

[Bulder]

so detectable vs measurable?

[E_L]

you can rest assured that response rate classification is very strict and will be checked stringently by authorities

[E_L]

they have strict criteria for it in the Ph3 ' Response is determined by the Lugano criteria and LYRIC'

[Bulder]

Yes, I assume that CR vs CMR is of minor importance then.

[E_L]

my gutfeel is that most epco response also are CMR, but if not ALL of them are, or if the trial criteria were not CMR they can not call it that

[E_L]

disclaimer; i am NOT a doctor

[lahn1]

Generelt, hvis man er på EMA’s agenda f.eks i denne uge/md. hvornår kan man så regne med at høre nyt når det handler om godkendelse eller ej ?

[Bulder]

Svært at sige. Sagen kan godt være på CHMP's dagsorden, uden at der bliver besluttet noget. Måske sender de sagen videre til PRAC (safety). Og så kan der gå lang tid.

[Bulder]

Men hvis sagen HAR været i PRAC, så kan det ske når som helst. De udsender hver fredag en meddelelse om hvilke stoffer, der er blevet godkendt/afvist.

[Bulder]

Vi har gennem tiden adskillige gange set dara på dagsordenen, men hvor der ikke er besluttet noget. Blot at sagsbehandlingen går videre.

[E_L]

On 20 May 2021, the Committee for Medicinal Products for Human Use (CHMP) adopted two positive opinions recommending changes to the terms of the marketing authorisation for the medicinal product Darzalex
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/darzalex-2

[Bulder]

So in a couple of weeks the EU comission will take the final, formal descision.

[Bulder]

Sometimes Genmab sends out messages, when CHMP recommends positive.

[E_L]

Amyloidosis
application was early november, pretty fast

[lahn1]

Tak Bulder

[peter12]

Bulder jeg tror CR er et RECIST kriterie og CMR et PET-CT men ellers ved jeg ikke

[Bulder]

Nederst i denne artikel står at recist-kriterier ikke kan bruges til lymfomer https://pri.rn.dk/Sider/19237.aspx

[E_L]

here is your release @Bulder . I was told they made it specially for you. https://ir.genmab.com/news-releases/news-release-details/genmab-announces-janssen-has-received-positive-chmp-opinion