FDA Approves Frontline Darzalex Regimen to Treat Patients With Multiple Myeloma

The Food and Drug Administration (FDA) has approved Darzalex (daratumumab) in combination with Velcade (bortezomib), Thalomid (thalidomide) and dexamethasone, also known as VTd, to treat patients who are newly diagnosed multiple myeloma and are eligible for autologous stem cell transplant (ASCT).

“Today’s approval is an important step forward for patients with multiple myeloma. There are now three different treatment combinations that include Darzalex for patients newly diagnosed with multiple myeloma, whether they are eligible for ASCT or not,” Dr. Jan van de Winkel, chief executive officer of Genmab, said in a press release.

The FDA based its approval on the phase 3 CASSIOPEIA trial that included more than 1,000 newly diagnosed patients. Part one of the trial showed a stringent complete response rate of 29% in patients who received the Darzalex regimen compared with 20% who received VTd alone following consolidation therapy.

Part two of the study examined progression-free survival (PFS). However, the median PFS has not been reached in either group as of the 18.8-month follow-up.

The overall response rate post-consolidation therapy was 93% with the addition of Darzalex and 90% with VTd alone.

The most commonly experienced serious side effects in part one included the following: neutropenia, lymphopenia, stomatitis and thrombocytopenia. In the Darzalex group, 35% of patients experienced infusion-related reactions. Treatment discontinuation occurred in both groups because of side effects or serious side effects.