Genmab — Juli 2019
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The U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for isatuximab for the treatment of patients with relapsed/refractory multiple myeloma (RRMM). The target action date for the FDA decision is April 30, 2020. Isatuximab is an investigational monoclonal antibody that targets a specific epitope on the CD38 receptor of a plasma cell.
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Hvornår forventer vi de sidste resultater for SC der skal anvendes som dokumentation til FDA?
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Fra sidste CC: So one needs indeed also the data from the PLEIADES study, an over 180-patient Phase II study. Janssen has that data. That data will be presented, I think, soon also at a conference. And that together, that data will be filed together with the COLUMBA data in both U.S. and Europe in the summer time frame. The exact timing is not clear to me, but that is the timing I've heard from our partner
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Horizon Therapeutics plc Submits Teprotumumab Biologics License Application (BLA) for the Treatment of Active Thyroid Eye Disease (TED) https://ir.horizontherapeutics.com/news-releases/news-release-details/horizon-therapeutics-plc-submits-teprotumumab-biologics-license
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