Table 1.

US FDA and EMA approved indications for daratumumab in multiple myeloma (MM).

Dara-SC#	Dara IV‡
Newly diagnosed MM (transplant ineligible)	Same in addition to
With bortezomib, melphalan, +prednisone (DVMP)*	With bortezomib, thalidomide,  + dexamethasone (DVTd): newly diagnosed MM (transplant eligible)*
With lenalidomide + dexamethasone (DRd)*	With pomalidomide + dexamethasone (DPd): relapsed/refractory MM
Relapsed/refractory MM
With lenalidomide + dexamethasone (DRd)*
With bortezomib + dexamethasone (DVd)*
As monotherapy: relapsed/refractory to three lines of therapy (including a PI + IMiD) or double refractory (to a PI + IMiD)
In patients whose prior therapy included a PI and an IMiD and who have demonstrated disease progression on the last therapy*

^#US FDA approved indications for Dara-SC.

^‡US FDA approved indications for Dara-IV.

^*EMA approved indications for daratumumab via SC administration or IV infusion.

D, daratumumab; d, dexamethasone; EMA, European Medicines Agency; FDA, Federal Drug Administration; IMiD, immunomodulatory agent; IV, intravenous; M, melphalan; P, pomalidomide; P, prednisone; PI, proteasome inhibitor; R, lenalidomide; SC, subcutaneous; T, thalidomide; V, bortezomib.