COBIMETINIB
Drug Details
- Generic Name
- COBIMETINIB
- Brand Names
- Cotellic
- Application Number
- NDA206192
- Sponsor
- Genentech, Inc.
- NDC Codes
- 1
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- COBIMETINIB FUMARATE
Indications and Usage
1 INDICATIONS AND USAGE COTELLIC ® is a kinase inhibitor indicated: For the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. ( 1.1 , 14.1 ) As a single agent for the treatment of adult patients with histiocytic neoplasms. ( 1.2 , 14.2 ) 1.1 Unresectable or Metastatic Melanoma COTELLIC ® is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, in combination with vemurafenib. 1.2 Histiocytic Neoplasms COTELLIC®, as a single agent, is indicated for the treatment of adult patients with histiocytic neoplasms.