Daratumumab: A Review in Combination Therapy for Transplant-Eligible Newly Diagnosed Multiple Myeloma
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ADIS DRUG EVALUATION
Daratumumab: A Review in Combination Therapy for Transplant‑Eligible Newly Diagnosed Multiple Myeloma Yvette N. Lamb1
© Springer Nature Switzerland AG 2020
Abstract Intravenous daratumumab (DARZALEX®), a human monoclonal antibody targeting CD38, is approved in the EU and USA for use in combination with bortezomib, thalidomide and dexamethasone for the treatment of adults with newly diagnosed multiple myeloma (MM) who are eligible for autologous stem cell transplantation. A subcutaneous formulation of daratumumab has also been approved in the EU and USA (DARZALEX FASPRO™) for use in MM. In the pivotal phase III CASSIOPEIA trial in adults with newly diagnosed, transplant-eligible MM, the addition of intravenous daratumumab to bortezomib, thalidomide and dexamethasone significantly increased the proportion of patients with a stringent complete response and significantly prolonged progression-free survival; overall survival data are not yet mature. Some facets of health-related quality of life were improved by the addition of daratumumab. The addition of daratumumab had a minimal effect on overall toxicity and the most common grade ≥ 3 adverse events with daratumumab combination therapy were haematological (e.g. neutropenia, lymphopenia). The approval of daratumumab as combination therapy in patients with newly diagnosed, transplant-eligible MM expands the range of MM treatment settings in which daratumumab is an option and the availability of the subcutaneous formulation will likely be of benefit to patients.
1 Introduction Multiple myeloma (MM) is a plasma cell neoplasm that accounts for ≈ 10% of haematological malignancies [1]. While MM remains incurable, relentless evolution in the treatment landscape has contributed to progressively improving clinical outcomes and clinicians treating patients
Enhanced material for this Adis Drug Evaluation can be found at https://doi.org/10.6084/m9.figshare.12678944. The manuscript was reviewed by: N. Callander, University of Wisconsin Carbone Cancer Center, Madison, WI, USA; C. Cerchione, Hematology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy; S. Knop, Medizinische Klinik und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany; S. J. Kumar, Hematology and Internal Medicine, Mayo Clinic, Rochester, MN, USA. Electronic supplementary material The online version of this article (https://doi.org/10.1007/s40265-020-01385-x) contains supplementary material, which is available to authorized users. * Yvette N. Lamb [email protected] 1
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Daratumumab: clinical considerations in transplant‑eligible newly diagnosed MM First-in-class CD38 monoclonal antibody Prolongs progression-free survival and induces deeper responses when added to bortezomib, thalidomide and dexamethasone Manageable tolerability profile when used as combination therapy
with newly diagnosed MM now have a vast array of drugs in their therape
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