Genmab — April 2018

[gentogen]

Der findes en enkelt, men noget hypotetisk case om dara og encephalopathy, idet en enkelt patient fik det værre efter dara som fjerde behandling i kombi med dexamethasone, tyleno og benadryl, men man ved ikke, om Dara var årsagen, da Little is known about the underlying pathophysiology of hyperammonemic encephalopathy as a complication of MM.

[gentogen]

No cases have been reported to specifically describe daratumumab-induced hyperammonemia, but considering our patient’s acute change in mental status following chemotherapy treatment, its contributions to the clinical presentation cannot be ignored

[gentogen]

Multiple Myeloma-Induced Hyperammonemic Encephalopathy | Murtaza | Journal of Hematology

Multiple Myeloma-Induced Hyperammonemic Encephalopathy

(www.thejh.org)

[GeorgeBest]

Tak gentogen. Vil resultatet af CHMP afgørelsen blive publiceret den 12/4?

[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...