Expanded US Approval Set To Take Janssen’s Darzalex Higher

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 multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double-refractory to a PI and IMiD. (Also see "Janssen/Genmab Win 1st Anti-CD38 In Multiple Myeloma" - Scrip, 17 November, 2015