Drug: Daratumumab (Darzalex, Janssen)
Status: Approved in combination with lenalidomide (Revlimid, Celgene) and dexamethasone, or bortezomib (Velcade, Millennium) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Significant Data:
- Approval was based on two randomized, open-label trials:
POLLUX trial (MMY3003)
- Demonstrated substantial improvement in progression-free survival (PFS) when daratumumab was added to lenalidomide and