Genmab — Maj 2020

[E_L]

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020 for the supplemental New Drug Application (sNDA) to expand the Prescribing Information to include KYPROLIS in combination with dexamethasone and DARZALEX (daratumumab) for patients with relapsed or refractory multiple myeloma based on data from the Phase 3 CANDOR study.

[E_L]

In February, a variation to the marketing authorization application was submitted to the European Medicines Agency to expand the indication for Kyprolis in relapsed multiple myeloma based on data from the Phase 3 CANDOR study.

[Sukkeralf]

Nice work E L ????

[Sukkeralf]

?????? Was a smiley

[Bulder]

very very nice

[Bulder]

[Sukkeralf]

[Bulder]

Så får vi ofa-godkendelse, TV-data og partneraftale lige oven i hinanden

[E_L]

yes, could be a great summer, for Genmab. (if markets don't crash again for a double bottom or something...) Jan will probably be in a good mood next week

[lahn1]

Exciting time ahead, but wouldn't mind a double bottom

[bibob]

C
ould Dara sc possibly be used off label allready now. ???

[E_L]

not sure in europe, but in US there is Pre-Approval Access via https://clinicaltrials.gov/ct2/show/NCT04264884?term=genmab+OR+daratumumab+OR+darzalex+OR+ofatumumab+OR+Teprotumumab+OR+Tisotumab+OR+camidanlumab+OR+Enapotamab+OR+ADCT-301+OR+duobody&lupd_s=02%2F11%2F2020&draw=2

[E_L]

if you have a doctor that is a bit creative, i would imagine he could get his patients on, specially in covid time. But i am not sure if it is used

[bibob]

Thx E L. - That could spare some time for the Doctors. And time is ( big ) money.

[bikube]

Kunne være et godt spørgsmål til Jan ved et evt. komende Q&A, hvor meget det bliver brugt.

[The_Joker]

Tror i godkendelsen af den subkutane version sender Halozymes (leverandøren af teknologien) nord på i dag? Eller bliver effekten ligeså beskeden som for Genmab?

[Solsen]

Markedet burde have kendskab til det i går i børsens åbningstid. Men et popup ville være dejligt at sælge på

[Bulder]

Off label brug forudsætter jo, at det er tilgængeligt.

[Solsen]

JNJ købte i Q419 et stort parti af det middel som dara skal opblandes i. Så de er vel parate.

[Bulder]

Jo,men de må vel ikke sende det ud på markedet, før det er godkendt. Med mindre det foregår i studie-regi.