Genmab — Maj 2025

[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%....

[Solsen]

Som jeg læser er det en diskutabel virkning og bivirkningsprofil i non-asiatiske pts mere end en fejl i rekruttering.

[lahn1]

Det kan også være derfor, men her siger de det lige ud, “We’re sitting here at the US FDA, and 25 patients were enrolled from the US,” said Daniel Spratt, MD, ODAC member and chairman and professor of radiation oncology at University Hospital Seidman Cancer Center, when explaining the reason why he voted no.

“Another word I kept coming back to was ‘sufficient,’ that sponsors should plan to enroll a sufficient number of US participants,” Ravi A. Madan, MD, ODAC member

[gentogen]

Med andre ord. De har for få patienter til at afgøre, om det er tilfældigheder eller ikke.