FDA Grants GSK and Genmab's Arzerra® (Ofatumumab) Breakthrou
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Der ligger mig bekendt ikke en BTD sbla til godkendelse hos FDA. Mon ikke vi er "in for a big surprise" på hvor lang tid FDAs behandling af ansøgningen tager?
Det her er noget vildt, men nu tror jeg en action date omkring ASH.
Der må vel være en eller anden logisk baggrund til at Ofa har fået BTD på dette meget sene tidspunkt - både generelt, men specifikt overfor GA101...
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Betegnelsen Breakthrough Therapy blev indført som en del af 2012 FDA Safety and Innovation Act (FDASIA) og har til formål at fremskynde den kliniske udvikling og processen for regulatorisk evaluering af lægemidler til behandling af
alvorlige eller livstruende sygdomme, når foreløbig klinisk evidens viser, at lægemidlet kan give en væsentlig forbedring på mindst ét klinisk signifikant endpoint i forhold til de tilgængelige behandlinger. Breakthrough Therapy-betegnelsen omfatter alle de procedurer, som Fast Track-status indebærer, og derudover en mere intensiv vejledning fra FDA omkring lægemidlets -
Det er alt for gode dage for os aktionærer. Den afgørende sentiment changer var BTD i Arzerra. Men vi skal have flere news til at underbygge flere kursstigninger.
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Det fortsætter.
Helt afgørende vending for mig at se med gennembruddet af 220.
http://onlinelibrary.wiley.com/doi/10.1002/emmm.201201929/full
De kan potentielt have gang i et antistofformat, der er mere effektivt end hidtil anvendte.Solsen
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The paper explained
PROBLEM:Despite clinical successes the efficacy of anti-cancer therapeutic mAbs needs further improvement. Currently, all antibodies are of the IgG isotype that engage Fcgamma receptors (FcγRs) to mediate activation of immune effector cells. In vitro results show that IgA anti-tumour antibodies are also able to mediate effective tumour cell killing. IgA antibodies engage Fcalpha receptor (FcαRI) that is expressed by different effector cells than FcγRs. However, the anti-tumour activity of IgA antibodies has not been tested in vivo.
RESULTS:
In this work, we report in vivo anti-cancer activity of IgA antibodies targeting epidermal growth factor receptor (EGFR) in both immunodeficient and immunocomptenent tumour models in mice. Since mice do not have FcαRI, we used mice transgenic for human FcαRI. We have found potent anti-tumour activity of IgA EGFR antibodies that greatly depended on the presence of human FcαRI transgene. We identified macrophages as the predominant effector cells mediating in vivo anti-tumour activity of IgA antibodies.
IMPACT:
These results demonstrate the anti-tumour activity of IgA antibodies in vivo and support the development of immunotherapeutic strategies against cancer based on targeting FcαRI.
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Genmabs antistoffer har isotypen IgG1, abgenix havde IgG2. Ingen har tidligere anvendt IgA isotypen og Winkel et al skriver, at dette format er potentielt mere effektiv i cancerbehandling.
Ganske interessant, hvis de også her kan vise vejen til en bedre behandling !
Solsen
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