Genmab — Juli 2019

[AaBforever]

Tjoh..måske manglede han noget at skrive om...er sommeren ikke agurketid?..:-D

[Legolas23]

Genmab er de-risked med Maia-godkendelse og SC to come.

[Bulder]

Martin Havtorn har før demonstreret en vis hang til det sensationsprægede. Hans overskrift er faktisk ikke rigtig: Selskabet har nu udsendt advarsler til alverdens sundhedsmyndigheder .. - Det gjorde de for flere mdr. siden. Her f.eks. NZ: https://medsafe.govt.nz/safety/DHCPLetters/DarzalexMarch2019.pdf

[Bulder]

Men MH har først opdaget det nu.

[Darvin]

Skandaløs journalistik må man sige. Advarsel ja, men yderst sjældent. I marts skrev Jansen at der havd været to fatale tilfælde idag knap 35.000 patienter

[Darvin]

Ud af

[JKY_VH]

Tak for opklaring Bulder.

[lahn1]

@EL 14:46- did we get results for each of the eight different cancer tested in InnovaTV 201?

[Solsen]

https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-selinexor-multiple-myeloma Måske vist før.

[E_L]

@lahn1 no, i think the last we got was the article in the Lancet earlier this year? they'll probably present more at a suitable conference?

[Doc4]

U.S. Food and Drug Administration has approved oral XPOVIO in combination with dexamethasone for the treatment of relapsed or refactory multiple myeloma in adult patients. Karyopharm expects XPOVIO to become commercially available in the U.S. on or before July 10, 2019.

[Peter_Panik]

Hvad mon det kommer til at betyde for Genmab?

[Darvin]

Den skal bruges til patienter, der tidligere har modtaget mindst fire andre behandlinger, og hvor sygdommen allerede viser resistens over for behandling med en række andre midler. Så det !

[Peter_Panik]

ok

[lahn1]

THX EL

[polle1]

God morgen og god dag

[Sukkeralf]

Just a moment...

(www.firstwordpharma.com)

[Sukkeralf]

The news of the approval was clearly a surprise to investors, sending Karyopharm's stock shooting up about 40%. The FDA's final decision is at odds with that of the Oncologic Drug's Advisory Committee (ODAC), which had voted 8-5 against recommending approval and instead advocated waiting for results from the ongoing Phase III BOSTON trial.

[Sukkeralf]

The company's initial Xpovio review was based on the Phase IIb STORM trial, which produced a response rate of 26% and an overall survival of 8.6 months- but paired with a 100% adverse event rate, and an 89% dose modification rate.

[Solsen]

Det er ikke voldsomt imponerende sukkseralf.