Genmab — Juni 2017

[Mcjean]

NICE har faktisk et godt ry som værende dygtige til at finde balancen mellem produkt, pris og virkning, at de måske fejler med Darzalex er så en anden sag, men mon ikke når det når en bredere label bliver godkendt

[Mcjean]

men indtil videre synes de pengene er brugt bedre andre steder end at give denne dyre behandling til ikke ret mange og det er jo så et prioriteringsspørgsmål, som jeg ikke skal gøre mig klog på.

[Helge_LarsenPI-redaktør]

Sorry Sukker..Sidder i møde. Smed linket for at fortælle at Trump var på banen igen over for medicinpriserne. Ved godt at han ikke har magt som han har agt.

[royal]

https://clinicaltrials.gov/ct2/show/NCT01946477
Er det ud fra denne her de har søgt?

[Bulder]

Kite får PR for sin CD19 CAR-T i R/R NHL http://www.targetedonc.com/news/ktec19-granted-priority-review-by-fda-for-nonhodgkin-lymphoma

[royal]

Sorry, Celgene

[JohnW]

Kan vi mon stadig forvente at få svar fra FDA i dag/i aften?

[Sukkeralf]

royal - nope ! this one:

[Sukkeralf]

ClinicalTrials.gov

(clinicaltrials.gov)

[Sukkeralf]

i dag eller mandag - en sjælden gang imellem går de et par dage over

[royal]

Thank you

[flottenschmecker]

Den her pdufa gør vist markedet lidt nervøst - volumen er helt væk

[JohnW]

Vi kan nok godt vente nogle dage endnu...når blot det er godt nyt

[royal]

Timer.....

[KWC]

Preliminary data shows responses achieved in 11 of 34 evaluable patients with cervical cancer treated with tisotumab vedotin
Next steps in clinical development of tisotumab vedotin in this indication under active consideration

[KWC]

Genmab Announces Preliminary Cervical Cancer Data from Tisotumab Vedotin Phase I/II Study

[KWC]

"The preliminary data we see in patients with cervical cancer treated with tisotumab vedotin are encouraging. We believe further development of this novel antibody-drug conjugate may be warranted in cervical cancer and are actively looking into possible next steps," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

[KWC]

Copenhagen, Denmark; June 16, 2017 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701). In Part 2 of the study, 11 of 34 evaluable patients in the cervical cancer cohort achieved a response; with a median time of treatment of 4.9 months, 7 responders are still ongoing or in follow up for progression. The safety profile of tisotumab vedotin was consistent with known MMAE based antibody-drug conjuga

[JKY_VH]

tak KWC

[KWC]

conjugates (ADC), including peripheral neuropathy and neutropenia. Additionally, conjunctivitis was identified as a tisotumab vedotin specific toxicity, which led to introducing of prophylactic management. In the cervical cancer cohort, 15 patients experienced one or more Grade 3 adverse events: gastro-intestinal related (5 patients), anemia (2 patients), infections (1 patient), neuropathy (2 patients), bleeding (2 patients), other (10 patients).