FDA approves Darzalex-based combination for first-line multiple myeloma treatment
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The FDA approved daratumumab in combination with bortezomib, thalidomide and dexamethasone for patients newly diagnosed with multiple myeloma who are eligible for autologous hematopoietic stem cell transplant, according to a press release issued by the manufacturer.
The FDA based this approval of daratumumab (Darzalex; Genmab, Janssen Oncology) — a human IgG1k monoclonal antibody that binds to CD38 — in part on data from part one of the randomized, open-label, phase 3 CASSIOPEIA study. The study included 1,085 patients newly diagnosed with multiple myeloma who were eligible for high-dose chemotherapy and autologous HSCT.
In part one of the study, researchers randomly assigned patients to receive induction and consolidation treatment with bortezomib (Velcade, Millennium/Takeda), thalidomide and dexamethasone with or without daratumumab.
The proportion of patients achieving a stringent complete response served as part one’s primary endpoint.
In the ongoing part two portion of the study — for which PFS serves as the study’s primary endpoint — researchers will randomly assign patients who achieved a response to either maintenance daratumumab at 16 mg/kg every 8 weeks for up to 2 years, or observation.
Results from part one — presented this year at ASCO Annual Meeting and simultaneously published in The Lancet — showed significantly more patients assigned daratumumab achieved stringent complete response (29% vs. 20%; OR = 1.6, 95% CI, 1.21-2.12) and minimal residual disease negativity at a 10–5 sensitivity threshold (64% vs. 44%; P < .0001).
“Today’s approval is an important step forward for patients with multiple myeloma,” Jan van de Winkel, PhD, CEO of Genmab, said in the release. “There are now three different treatment combinations that include Darzalex for patients newly diagnosed with multiple myeloma, whether they are eligible for [autologous HSCT] or not. We are grateful for the efforts of the [French Intergroupe Francophone du Myelome], [Dutch-Belgian Cooperative Trial Group for Hematology Oncology] and Janssen that led to the strong data from the CASSIOPEIA trial, which formed the basis of this new approval.”
FDA previously granted this drug application priority review.
Reference:
Moreau P, et al. Lancet. 2019;doi:10.1016/S0140-6736(19)31240-1.