Updated 9th May 2018 - The FDA has just announced that Darzalex (daratumumab) has approval to become the first line (which means the first choice) treatment for patients with newly diagnosed multiple myeloma who are ineligible for a stem cell transplant (ASCT). OncLive reports that results from a new Phase III study called ALCYONE show that over 90% of patients responded well to the treatment and after 18 months of treatment 71.6% of them were still progression-free.
Approvals, however, don’t necessarily mean medicines will be available to all multiple myeloma patients at the same time. This may be due to the medicine not yet being approved in a country, or being approved but not available because of bureaucratic delays. In most countries, however, importation on a ‘named patient’ basis allows patients and doctors to already import such medicines .Although it requires guidance and assistance to ensure efficiency along the way, importing of medicines is possible. If you or someone you know needs more information about importing medicine, you can find information on our home page about how we can help. Our team delivers not yet approved medicines around the world on daily basis, with service that’s highly rated by doctors and patients.
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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.
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
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