FDA Approval Summary: Vemurafenib for the Treatment of Patients with Erdheim‐Chester Disease with the BRAFV600 Mutation

• Published in: The oncologist (Dayton, Ohio) Vol. 23; no. 12; pp. 1520 - 1524
• Main Authors: Oneal, Patricia A., Kwitkowski, Virginia, Luo, Lola, Shen, Yuan Li, Subramaniam, Sriram, Shord, Stacy, Goldberg, Kirsten B., McKee, Amy E., Kaminskas, Edvardas, Farrell, Ann, Pazdur, Richard
• Format: Journal Article
• Language: English
• Published: Hoboken, USA John Wiley & Sons, Inc 01.12.2018
• Subjects: BRAFV600 mutations; Histiocytosis; Non‐Langerhans cell histocytosis; Regulatory Issues: FDA; Vemurafenib; Zelboraf

On November 6, 2017, the U.S. Food and Drug Administration (FDA) granted regular approval to vemurafenib for the treatment of adult patients with Erdheim‐Chester disease (ECD) with BRAFV600 mutation. ECD is a type of histiocytosis, a rare disorder characterized by an abnormal accumulation and behavi...