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Darzalex March Continues with EU Approval

 
• By Alexandra Shimmings

The latest approval for Johnson & Johnson's monoclonal antibody therapy Darzalex in multiple myeloma keeps the product firmly on course as a much-needed new option in relapsed/refractory patients but competition in the market is hotting up all the time.

chemist

The European Commission has now granted conditional approval to Janssen-Cilag's (Johnson & Johnson) first-in-class anti-CD38 antibody Darzalex (daratumumab; licensed form Genmab) for use in melanoma following a CHMP positive opinion in April. (Also see "Accelerated EU Committee Nod for J&J/Genmab's Darzalex " - Scrip, 2 April, 2016.)

The approval, the second for the novel product after it was given an earlier-than-expected go-ahead by the US FDA last November, means it will come to the EU market only...

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