FDA approves Darzalex (daratumumab) plus pomalidomide and dexamethasone for multiple myeloma- Janssen Biotech

Janssen Biotech announced that the FDA has approved the immunotherapy Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide (an immunomodulatory agent) and a proteasome inhibitor (PI). Clinical trial results showed an overall response rate (ORR) of 59.2 percent with Darzalex in combination with pomalidomide and dexamethasone in these patients.

This new indication for Darzalex is supported by data from the Phase Ib EQUULEUS study, which showed that the combination of Darzalex with pomalidomide and dexamethasone resulted in an ORR of 59.2 percent, with very good partial response (VGPR) achieved in 28.2 percent of patients. Complete response (CR) was achieved in 5.8 percent of patients; stringent CR (sCR) was achieved in 7.8 percent of patients; and partial response (PR) was achieved in 17.5 percent of patients. The median time to response was one month (range: 0.9 to 2.8 months), and the median duration of response was 13.6 months (range: 0.9+ to 14.6+ months).

Overall, the safety of the Darzalex combination therapy was consistent with the known safety profiles of Darzalex monotherapy and pomalidomide plus dexamethasone, respectively. Warnings and precautions in the Prescribing Information include: infusion reactions, interference with cross-matching and red blood cell antibody screening, neutropenia and thrombocytopenia.