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Friday, July 27, 2018

Janssen gets broader Euro label OK for myeloma med


Johnson & Johnson announces CHMP recommendation for Darzalex  Janssen Pharmaceutical of Johnson & Johnson announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, has recommended broadening the existing marketing authorisation for Darzalex for use as frontline therapy. The recommendation is for the use of daratumumab in combination with bortezomib, melphalan and prednisone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant, or ASCT. The CHMP’s recommendation is based on results from the randomised, open-label, multicentre Phase 3 ALCYONE study. A final decision regarding the approval of daratumumab for newly diagnosed patients is expected from the European Commission in the coming months.
https://bit.ly/2LK7pDE

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