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Expanded US Approval Set To Take Janssen’s Darzalex Higher

 
• By Alexandra Shimmings

Janssen’s multiple myeloma therapy, Darzalex, has won an additional US approval for use earlier in the treatment paradigm, building momentum for a product that has already got off to a strong start.

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The US FDA has approved Janssen Biotech Inc.’s Darzalex (daratumumab, licensed from Genmab AS) in combination with lenalidomide (Celgene Corp.’s Revlimid) and dexamethasone, or bortezomib (Velcade) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. This go-ahead for second-line use brings the anti-CD38 monoclonal forward in the treatment arc for this disease.

Darzalex was first approved in the US, rather earlier than expected, almost exactly a year ago to treat patients with...

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