The US Food and Drug Administration has granted a Breakthrough Therapy Designation to cobimetinib in the treatment of patients with histiocytic neoplasms (Erdheim-Chester Disease, Rosai-Dorfman, Langerhans Histiocytosis), who do not bear the BRAF V600 mutation. This is not only a great step forward for BRAF-negative ECD patients but for all histiocytosis.
FDA Granted Breakthrough Designation
