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...