Risk of RAS-Mutant Malignancy Progression and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS Syndrome) associated with Zelboraf® (vemurafenib)

Roche would like to inform healthcare professionals of the risk of RAS-mutant malignancy progression and DRESS syndrome associated with Zelboraf® (vemurafenib). The risk of RAS-mutant malignancy progression is based on a single report from a literature article about a 76 year-old male patient with stage IV melanoma in whom accelerated growth of a pre-existing NRAS-mutated chronic myelomonocytic leukemia (CMML) was observed shortly after initiation of treatment with Zelboraf®. Based on its mechanism of action, Zelboraf® may cause progression of cancers associated with RAS mutations. Zelboraf® should be used with caution in patients with prior or concurrent cancers associated with RAS mutations. In addition, cases of DRESS syndrome have been reported with the use of Zelboraf® with onset ranging from 7 to 25 days. Zelboraf® treatment should be permanently discontinued if a patient develops DRESS syndrome. The package insert for Zelboraf® will be updated to reflect the new safety information. Published: 31 Jul 2013

Dear Healthcare Professional Letters