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ALCYONE Paves Way For J&J/Genmab's Darzalex In Frontline Myeloma

Data supporting a role for J&J/Genmab's anti-CD38 monoclonal antibody in newly diagnosed multiple myeloma are "as good as could be expected," but the backbone regimen in the trial is rarely used in the US.

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Genmab AS/Johnson & Johnson's anti-CD38 antibody Darzalex is now poised for a broader role as part of a combination regimen in frontline treatment of multiple myeloma, following a top-line release of positive Phase III data from the ALCYONE study, which was stopped early due to the efficacy findings.

Darzalex (daratumumab) initially was approved in November 2015 as a monotherapy for patients who have had three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory drug

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