Genmab — April 2018

[E_L]

It will produce Meeting highlights on the Friday after Committee plenary.

[E_L]

After years of dosing thousands with Dara, this has never come up as an issue. It doesnt worry me.

[E_L]

This study, just new in March - Daratumumab in Treating Transplant-Eligible Participants With Multiple Myeloma - already started recruiting. Moving fast. https://clinicaltrials.gov/ct2/history/NCT03477539?A=3&B=4&C=merged

[Bulder]

Tak gentogen. Det virker ud fra artiklen som om det mere er en (sjælden) komplikation ved sygdommen end det er bivirkninger darzalex. Men når der har været beretninger efter højdosis kemo har PRAC sikkert taget det op for at udelukke enhver tvivl.

[Bulder]

GB: Det er ikke CHMP, der har møde i disse dage - det er PRAC, sikkerhedskomitéen. CHMP har møde 23.-26. april med highlights 27. april.

[GeorgeBest]

Tak Bulder. Tror du PRAC publicerer deres konklusion den 12/4?

[E_L]

my response was to the PRAC, so yes. But as with last CHMP they may not include comments on Dara...(?)

[E_L]

forgot the link i see http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000353.jsp&mid=WC0b01ac05805a21cf

[Bulder]

Ja, PRAC udgiver også highlights, det bliver så i dette tilfælde 13/4. Og så må vi se om de har taget stilling til emnet. Mht CHMP's generelle anbefaling (eller det modsatte) af D-VMp tror jeg vi skal regne med august ud fra det Eatwell har sagt og gentaget på pressemødet i dag.

[Bulder]

Og tak til jkj for at have opdaget dette emne.

[E_L]

did anyone here actually go the annual meeting?

[GeorgeBest]

AGM http://ir.genmab.com/releasedetail.cfm?ReleaseID=1063329

[E_L]

CNBC catching on
https://www.cnbc.com/2018/04/10/reuters-america-biotech-group-genmab-aims-to-own-bigger-share-of-new-drug-pipeline.html

[E_L]

"We are now testing it in more than 15 solid cancers," de Winkel said (on dara)

[GeorgeBest]

wauw - 15 only for Darzalex. Op top of that comes tv and axl

[E_L]

sounds good, right? that is why we are up a huge 1/2 dkk...

[Solsen]

The market must wake up soon !

[Bulder]

Det må være fordi han regner de 4 varianter af tyktarmskræft for selvstændige former at han får det til 15. Ellers er der kun 12 med nivo, eller 13 hvis dara-atezo i nsclc er en særlig form.

[E_L]

i think you have another question for Q&A

[E_L]

Safety and efficacy of daratumumab in dialysis-dependent renal failure secondary to multiple myeloma - in Haematologica journal - http://www.haematologica.org/content/early/2018/04/03/haematol.2018.191122.full.pdf+html