SOUTH SAN FRANCISCO (dpa-AFX) - The U.S. Food and Drug Administration said it expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease or ECD, a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD. The FDA granted the approval of Zelboraf to Hoffman-LaRoche Inc, a subsidiary of Roche Holdings (RHHBY).
ECD is a slow-growing blood cancer that originates in the bone marrow. ECD causes an increased production of histiocytes, a type of white blood cell. Excess histiocytes can result in tumors infiltrating many organs and tissues throughout the body, including the heart, lungs, brain and others. ECD is estimated to affect 600 to 700 patients worldwide. Approximately 54 percent of patients with ECD have the BRAF V600 mutation. Patients with ECD have very limited life expectancies.
Zelboraf is a kinase inhibitor that works by blocking certain enzymes that promote cell growth.
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