Genmab — September 2015
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FDAs deadline til at træffe beslutning er tidligere end den er for dara.....?
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celcius - nu er Kyprolis mest af alt en konkurrent til Velcade, da det er samme virkningsmekanisme. Daratumumab bliver ligeledes testet i kombination med kyprolis og efterhånden som Kyprolis muligvis overtager Velcades plads, så vil Daratumumab-kombierne med Kyprolis også fylde mere.
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Snart kommer der formentlig endnu en proteasome inhibitor på markedet og denne er oral, så markedet bliver mere og mere komplekst. Selv om daratumumab kan kombineres med alle, så gør det bare hele markedet mere broget og derfor også sværere at gennemskue, hvad der bliver golden standard i de forskellige linier. Men helt sikkert godt at Genmab/Janssen formentlig bliver den første til at sætte sig bredt i MM markedet med et antistof. Vi ser hvor svært det er at smide Rituxan ud af markedet
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Fra Nordea"Genmab stiger i dag, efter at selskabets lægemiddel mod leukæmi får særstatus hos
de amerikanske sundhedsmyndigheder, som reducerer ansøgningstiden. Med til at
sende aktien op er desuden, at et studie med selskabets vigtigste lægemiddel mod
knoglemarvskræfter viser gode resultater. Resultaterne, som endnu ikke er blevet
bekræftet af Genmab, viser, at lægemidlet er i stand til at forlænge levetiden med
imponerede 17 måneder (median) for meget syge kræftpatienter, der allerede har været -
igennem flere andre kræftbehandlinger. Dette er data, som stammer fra registreringsstudiet
med Daratumumab, som pt. behandles af de amerikanske sundhedsmyndigheder,
men hvor vi indtil i dag ikke har kendt den eksakte overlevelse.
For at sætte de 17 måneder i perspektiv, så er den forventede levetid for disse syge
patienter 6-9 måneder, hvor det formentlig er tættest på seks måneder. Det lover
godt for en godkendelse af lægemidlet, der står hovedparten af den fremtidige indtjening i Genmab. -
Ved ikke om det har været nævnt tidligere, men Nordea skriver i dag at "At the ASH meeting on Hematologic Malignancies on17-19 September in Chicago (sub-meeting to the large ASH annual meeting in December), one of the investigators in the Daratumumab clinical programme was interviewed for ASH Clinical News. In the interview, Professor Peter Voorheesfrom The University of North Carolina Chapel Hill notes that while the median overall survival for DARAin the pivotal SIRIUS study presented at ASCO
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was not established (NE) as illustrated below, the data has now matured. Hence, according to Professor Voorhees,the median overall survival has now been reached and amounts to an impressive 17+months. These data have not been confirmed by the companies (J&J/Genmab),though. To put the 17+ monthsintocontext, the patients in the SIRIUS study were extremely ill and refractory with fiveprior lines of therapy, a median time from diagnosis of about fiveyears, 20% of patients hadhigh-risk genetic profi
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95% were double-refractory, and 66% were refractory to “three of the big four drugs” commonly used in myeloma. Many of the patientswere so-called end-stage myeloma patients and hence the expected overall survival is about6-9 months maximum(likely closer to six). Furthermore, when looking at the pivotal study for Amgen’s carfilzomib in less sick patients, the overall survival was 15.4 months.
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n this case, one should bear in mind that 50% of the patients in the DARA SIRUS study had also received Carfilzomib, underpinning the impressive response and survival data further. The FDA’sapproval data for DARA, based on the SIRIUS data, the Breakthrough Therapy Designation and the Priority Review is 9March, but we do not see it as unlikely with an approval already in 2015
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Link til interview (3:20min inde): https://www.youtube.com/watch?v=7Tkp88aLW1M&noredirect=1
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