Daratumumab approved as multiple myeloma treatment
Updated - 7 Dec 2017
The FDA approval of a promising new drug is offering new hope to multiple myeloma patients who have already been through various treatments. Daratumumab has been approved in the USA for the treatment of patients with multiple myeloma1 who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent2.
Update: daratumumab (Darzalex) is now approved for multiple myeloma in:
- Europe, approved by the European Medicines Agency (EMA) on May 20, 2016
- Australia, approved by the Therapeutic Goods Association (TGA) on July 17, 2017
Daratumumab (Darzalex) for Multiple Myeloma
This means that multiple myeloma patients who have received at least three separate treatments have a new medicine in their treatment options.
Multiple myeloma is a form of blood cancer that occurs in infection-fighting plasma cells (a type of white blood cell) found in the bone marrow. These cancerous cells multiply, producing an abnormal protein and pushing out other healthy blood cells from the bone marrow1. Daratumumab is a monoclonal antibody (it is cloned from a single parent cell) that works by helping certain cells in the immune system attack the cancer cells .
If daratumumab (Darzalex) is not available in your country then you can buy the medicine on TheSocialMedwork with a treating doctor’s prescription.
Latest developments with daratumumab (Darzalex)
Since this article was first written, Darzalex (daratumumab being the active ingredient) has been submitted and approved for combination treatments, giving patients two vital new options.
The first FDA approval for treating multiple myeloma was as a monotherapy, however since then It received additional approvals in November 2016 in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy.
In June, 2017 the U.S. Food and Drug Administration (FDA) also approved the medicine Darzalex (daratumumab) in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies including the commonly used lenalidomide (an immunomodulatory agent) and a proteasome inhibitor. Clinical trial results showed an overall response rate of 59.2 percent with Darzalex in combination with pomalidomide and dexamethasone in patients.
- 1. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm472875.htm
- 2. http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/761036s000lbl.pdf
- 3. http://meetinglibrary.asco.org/content/150339-156
- 4. http://www.nejm.org/doi/pdf/10.1056/NEJMoa1506348
DISCLAIMER: Nothing can replace the care of your clinician or doctor. Please do not make changes to your treatment or schedules without first consulting your healthcare providers. This article is not intended to diagnose or recommend a specific treatment.