Darzalex Setback In NHL Raises Stakes For First-Line Myeloma Approval
The pressure is increasing for Genmab and Janssen to report strong first-line multiple myeloma data for recently launched cancer therapy Darzalex, after development of the drug has been suspended for three hematological indications.
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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.
Scrip offers some top topics to monitor as second-quarter biopharmaceutical sales and earnings start to be unveiled. First out of the blocks will be Johnson & Johnson and Novartis AG. Recent and coming launches, pricing strategies, M&A and the biosimilar landscape are key themes to watch out for as the duo and other players update at their half-year points.
The EU's CHMP has given the go ahead to extend the EU licence for Janssen/Genmab's Darzalex to include its use earlier in the treatment paradigm, bringing into line with the US label and its rivals.