What is the generic name?

VEMURAFENIB

What is the Trade Name for VEMURAFENIB?

ZELBORAF

What are the Indications for VEMURAFENIB?

• 1 INDICATIONS AND USAGE ZELBORAF ¬Æ is a kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. ( 1.1 , 2.1 ) ZELBORAF ¬Æ is indicated for the treatment of patients with Erdheim- Chester Disease with BRAF V600 mutation. ( 1.2 , 2.1 ) Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma ( 2.1 , 5.2 ) 1.1 Unresectable or Metastatic Melanoma ZELBORAF ¬Æ is indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E mutation as detected by an FDA-approved test. Limitation of Use: ZELBORAF is not indicated for treatment of patients with wild-type BRAF melanoma [see Warnings and Precautions (5.2) ] . 1.2 Erdheim-Chester Disease ZELBORAF ¬Æ is indicated for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.

References: https://open.fda.gov/