What Darzalex is?
DARZALEX® (daratumumab) is a prescription medicine used to treat a type of blood cancer called multiple myeloma. DARZALEX® is not chemotherapy. It is a targeted monoclonal antibody that helps slow or stop the progression of multiple myeloma in several ways.
Daratumumab is an anti-cancer medication indicated for the treatment of:
- Multiple Myeloma: In the patient who had received at least three prior therapies.
- Newly Diagnosed Multiple Myeloma: Patients who are not able for autologous stem cell transplant may receive Daratumumab with a combination of the melphalan, bortezomib, and prednisone.
- As a Monotherapy: Darazalex can be also taken by the patients with relapsed and refractory multiple myeloma.
What Daratumumab is?
- In November 2015, the U.S. Food and Drug Administration (FDA) approved daratumumab for treatment of multiple myeloma in people who had received at least three prior therapies. In May 2016 daratumumab was also conditionally approved by the European Medicines Agency for treatment of multiple myeloma.
- In November 2016, the FDA approved daratumumab in combination with lenalidomide or bortezomib and dexamethasone for the treatment of people with multiple myeloma who have received at least one prior therapy.
- In May 2018, the FDA expanded the approval of daratumumab for use in combination with bortezomib, melphalan and prednisone to include the treatment of people with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.