Genmab — Maj 2025

[E_L]

maybe there is more in here, i didn't go through it -
Oncologic Drugs Advisory Committee (ODAC) Meeting
May 20, 2025- https://www.fda.gov/media/186525/download

[lahn1]

ODAC 6-2 i favør for Darzalex i SMM

[Helge_LarsenPI-redaktør]

Godmorgen

[ProinvestorNEWS]

FDA cancer panel gives thumbs up to J&J's Darzalex, votes nay on Roche's Columvi https://firstwordpharma.com/story/5964785

[LP90]

Godmorgen

[transalp]

Go morgen..

[bibob]

God morgen.

[E_L]

Dr Falchi on the Safety of Fixed-Duration Epcoritamab Plus Lenalidomide/Rituximab in R/R Follicular Lymphoma https://www.onclive.com/view/dr-falchi-on-the-safety-of-fixed-duration-epcoritamab-plus-lenalidomide-rituximab-in-r-r-follicular-lymphoma

[E_L]

JNJ press release - U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma - https://www.jnj.com/media-center/press-releases/u-s-fda-oncologic-drugs-advisory-committee-votes-in-favor-of-the-benefit-risk-profile-of-darzalex-faspro-daratumumab-and-hyaluronidase-fihj-for-high-risk-smoldering-multiple-myeloma

[NiklasZ]

Så er aktien brudt ud af den nedadgående trend kanal igen. Lad os se om det kan holde denne gang.

[Solsen]

Ret interessant melding på Columvi. Stoffet virker tilsyneladende ikke så godt på non-asiatiske pts.

[Plimsoller]

Enig Solsen, og som E L skrev, så vil et nyt fase 3 studie med flere US pts tage år.

[E_L]

I guess the moral of the story is if you lost money in the first quarter in biotech, you have plenty of good company. https://x.com/MBbiotech/status/1925123717287346356

[gentogen]

Egentlig ret utroligt, at de ikke havde styr på deres geografiske fordeling af patienter, men ifølge oprindelige link fra EL, så havde kun få af de i princippet medvirkende amerikanske klinikker i praksis deltaget

[E_L]

yes, i am surprised too, for such a large firm, and surely they will have been in touch with the FDA during the trial.. here is a bit more:

[E_L]

Asia stymies Columvi's expansion
21 May 2025

Starglo isn't applicable to a US population, an adcom rules. https://www.oncologypipeline.com/apexonco/node/1334

[lahn1]

Har ikke set nærmere på patient grp men kunne Columvi's rekrutterings issues være pga af den samtidige rekruttering i EPCORE DLBCL

[lahn1]

De har kun brugt 2 år på STARGLO, og kunne vel nok have fået 3-4 år af FDA til at færdiggøre forsøget. Så den mest oplagte grund er at konkurrence fra ande behandlings regimer bl.a. EPCORE 1+2+4. Er det forkert set at dette er et bragging point for Genmab ?

[E_L]

good thought

[E_L]

by the way, ODAC also voted 5 to 4 against the risk/benefit profile of UGN-102 for bladder cancer ; the company UroGen Pharma -48%....