Generic Name: daratumumab
Drug Class: Targeted Therapy Medications
Company: Janssen Therapeutics
Approval Status: Approved
Generic Version Available: No
Darzalex is a CD38 inhibitor approved for newly diagnosed or previously multiple myeloma, in combination with various other medications. Darzalex Faspro is a newer formulation that can be given by subcutaneous injection rather than IV infusion.
Darzalex is a monoclonal antibody that binds to the CD38 protein on myeloma cells and helps the immune system recognize and attack the cancer. Darzalex Faspro combines daratumumab and hyaluronidase to enable subcutaneous (under the skin) injection.
The CASTOR and POLLUX trials showed that Darzalex slows progression of multiple myeloma. The MAIA study found that a Darzalex combination regimen improved outcomes in newly diagnosed patients who are ineligible for stem cell transplants, while the CASSIOPEIA trial showed the same for transplant-eligible people.
The COLUMBA trial showed that Darzalex Faspro injections work as well as IV administration of the original Darzalex formulation. Darzalex was first approved in 2015. Darzalex Faspro was approved in 2020.
The original Darzalex formulation is administered as an intravenous infusion. The dose, schedule and duration of treatment vary based on the other medications used with it. Darzalex Faspro is administered as a subcutaneous injection into the abdomen.
Common adverse events include infusion reactions, fatigue, nausea, diarrhea, constipation, muscle, joint and back pain, fever, chills, dizziness, insomnia, cough, shortness of breath, upper respiratory tract infections, bronchitis, pneumonia, swelling and peripheral neuropathy. It can cause depletion of white blood cells (neutropenia) and platelets (thrombocytopenia), which can lead to infections and easy bleeding.
For More Info: https://www.darzalex.com/
Co-Pay Program Info: https://www.darzalex.com/patient-support/cost-support
Patient Assistance Program Info: https://www.darzalex.com/patient-support/cost-support
Last Reviewed: May 3, 2020