Darzalex Faspro

Darzalex Faspro is a subcutaneous formulation of daratumumab combined with hyaluronidase-fihj. It's primarily used to treat multiple myeloma and light chain amyloidosis. This medication is administered as an injection under the skin in the stomach area (abdomen), taking only about 3-5 minutes to administer, which is significantly faster than the original Darzalex intravenous formulation that takes hours[1][4][5]. ## Composition and Mechanism of Action Darzalex Faspro contains two active components: - Daratumumab: A CD38-directed cytolytic antibody that targets the CD38 protein found on multiple myeloma cells - Hyaluronidase-fihj: An endoglycosidase that helps the medication reach cells when given as a subcutaneous injection[1][5] The medication works by binding to the CD38 protein on multiple myeloma cancer cells, which kills these cells and enhances the immune system's ability to fight cancer[1]. ## FDA-Approved Indications Darzalex Faspro is approved for: 1. **Multiple Myeloma**: - In newly diagnosed patients who are: - Eligible for autologous stem cell transplant (in combination with various drug regimens) - Ineligible for autologous stem cell transplant (in combination with various drug regimens) - In relapsed or refractory multiple myeloma patients who have received at least one prior therapy - As monotherapy in patients who have received at least three prior lines of therapy[3][6][9] 2. **Light Chain (AL) Amyloidosis**: - In newly diagnosed adult patients (in combination with bortezomib, cyclophosphamide, and dexamethasone)[7] ## Administration Darzalex Faspro is administered as a subcutaneous injection in the abdomen over approximately 3-5 minutes by a healthcare professional[4][5]. This is a significant advantage over the original Darzalex formulation, which requires intravenous infusion over several hours[1]. ## Development History Darzalex Faspro was first approved by the FDA on May 1, 2020[6]. It has received several subsequent approvals for additional indications, including approval for light chain amyloidosis on January 15, 2021[7]. Most recently, on July 30, 2024, the FDA approved Darzalex Faspro in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for induction and consolidation in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant[10]. The medication is manufactured by Johnson & Johnson Innovative Medicine (formerly Janssen) and was developed in collaboration with Genmab[6][7].

Brand names

Darzalex Faspro

Other names

daratumumab and hyaluronidase-fihj