Genmab — Maj 2025

[lahn1]

ja tak ! men det er desværre nok kun en stakket rist. Alt ser jo fint ud undtagen at de alt for få USA patienter, som koster dem godkendelsen. Kan de mon få lov til at rekruttere nogle flere USA patienter og og på den måde udvide US-n ?

[lahn1]

rist = frist

[E_L]

ODAC is an Advisory Committee; so the FDA could even theoretically deviate from their advice. But they can also follow it and there is not enough confirmation for full approval and approval could be withdrawn. Genentech could recruit additional US patients; but it would take years wouldn't it...

[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