Genmab — Maj 2025
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@RobertoBoreaMD
Final #CHRYSALIS trials results: #Amivantamab delivers durable responses in #METex14 #NSCLC, even after MET TKI failure. https://x.com/RobertoBoreaMD/status/1924563968221122751
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The efficacy and safety of Tisotumab vedotin in the treatment of recurrent/metastatic cervical cancer: a systematic review and meta-analysis of single-arm studies https://www.frontiersin.org/journals/pharmacology/articles/10.3389/fphar.2025.1538980/full
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wow....
ODAC Votes STARGLO Trial Not Applicable to US Patients With DLBCL https://www.targetedonc.com/view/odac-votes-starglo-trial-not-applicable-to-us-patients-with-dlbcl -
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 But they can also follow it and there is not enough confirmation for full approval and approval could be withdrawn.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...
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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 -
Godmorgen
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FDA cancer panel gives thumbs up to J&J's Darzalex, votes nay on Roche's Columvi https://firstwordpharma.com/story/5964785
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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
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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 -
Enig Solsen, og som E L skrev, så vil et nyt fase 3 studie med flere US pts tage år.
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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
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