By Admin at 7 Jan 2016, 12:49 PM

Multiple myeloma, a form of blood cancer, is relatively rare in the United States; fewer than 27,000 new cases were diagnosed in 2015. However, multiple myeloma remains one of the most challenging forms of cancer to treat.

At this time, myeloma is rarely curable. Typical treatments, which may involve chemotherapy, radiation and other medications, may cause the cancer to go into remission for a period of time, but it virtually always comes back again.

As a result, “most patients never really finish treatment,” according to the American Cancer Society. New and more effective treatments are urgently needed for this disease, making the U.S. Food and Drug Administration’s (FDA) recent approval of Darzalex (daratumumab) all the more important.

In November 2015, the FDA granted accelerated approval for Darzalex, which is a first-in-class immunotherapy treatment (a monoclonal antibody), which works by helping your immune-system cells attack cancer cells.

Darzalex is approved for patients who have received at least three prior treatments for multiple myeloma, meaning the disease has become resistant to the other treatments or has progressed within a short period of time after the last treatment.

Darzalex clinical trial investigator Paul G. Richardson, M.D., Clinical Program Leader and Director of Clinical Research, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, said:

“Multiple myeloma is a highly complex disease and remains incurable, with almost all patients relapsing or becoming resistant to therapy … With DARZALEX, we have a promising new immunotherapy, which has shown pronounced efficacy as a single agent with an acceptable adverse event profile.

This is especially important for treating these heavily pre-treated patients in whom all of the major classes of currently available medicines have failed.”

The FDA accelerated approval was based on two open-label studies:

• In a study of 106 patients receiving Darzalex, 29 percent experienced complete or partial reduction in their tumor burden, lasting an average of 7.4 months.
• In a study of 42 patients receiving Darzalex, 36 percent had complete or partial reduction in their tumor burden.
  
  

Darzalex is given as an infusion; potential side effects included the following:

• Infusion-related reactions (experienced by half of patients)
• Fatigue
• Back pain
• Fever and nausea
• Cough
• Low white blood cell count
• Low red blood cell count (anemia)
• Low levels of blood platelets (thrombocytopenia)

If you or a loved one has multiple myeloma that has become resistant to other therapies, consider talking with your oncologist about whether or not Darzalex may be an appropriate option for you.

Sources:
U.S. Food and Drug Administration November 16, 2015
Johnson & Johnson November 16, 2015
American Cancer Society, Multiple Myeloma

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