For the Beacon news article on the approval, see:
"Darzalex (Daratumumab) Approved By FDA For Multiple Myeloma," The Myeloma Beacon, Nov 17, 2015
(Yes, the link to the Beacon news article was added to this posting once the article was published. We thought it might be useful, however, to have it in this thread.)
This FDA press release also has basic information about the approval:
"FDA Approves Darzalex For Patients With Previously Treated Multiple Myeloma", Nov 16, 2015
Key excerpts from the press release:
Today the U.S. Food and Drug Administration granted accelerated approval for Darzalex (daratumumab) to treat patients with multiple myeloma who have received at least three prior treatments. Darzalex is the first monoclonal antibody approved for treating multiple myeloma ...
Darzalex injection, given as an infusion, is a monoclonal antibody that works by helping certain cells in the immune system attack cancer cells.
The safety and efficacy of Darzalex were demonstrated in two open-label studies. In one study of 106 participants receiving Darzalex, 29 percent of patients experienced a complete or partial reduction in their tumor burden, which lasted for an average of 7.4 months. In the second study of 42 participants receiving Darzalex, 36 percent had a complete or partial reduction in their tumor burden.
The most common side effects of Darzalex were infusion-related reactions, fatigue, nausea, back pain, fever and cough. Darzalex may also result in low counts of infection-fighting white blood cells (lymphopenia, neutropenia, and leukopenia) or red blood cells (anemia) and low levels of blood platelets (thrombocytopenia).
Blood banks should be informed that patients are receiving Darzalex because the drug may interfere with certain tests that are done by blood banks (such as antibody screening) for patients who need a blood transfusion. Women who are pregnant should not use Darzalex, and women planning to become pregnant should use effective contraceptives during and for at least three months after treatment.
Update (May 24, 2016): Darzalex also has now been approved in Europe; see this Beacon news article with additional information:
"Darzalex approved in Europe," The Myeloma Beacon, May 24, 2016
