What is the generic name?

ENCORAFENIB

What is the Trade Name for ENCORAFENIB?

BRAFTOVI

What are the Indications for ENCORAFENIB?

• 1 INDICATIONS AND USAGE BRAFTOVI is a kinase inhibitor indicated: in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test. ( 1.1 , 2.1 ) in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy. ( 1.2 , 2.1 ) Limitations of Use BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma or wild-type BRAF CRC. ( 1.3 , 5.2 ) 1.1 BRAF V600E or V600K Mutation-Positive Unresectable or Metastatic Melanoma BRAFTOVI ¬Æ is indicated, in combination with binimetinib, for the treatment of patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, as detected by an FDA-approved test [see Dosage and Administration (2.1) ] . 1.2 BRAF V600E Mutation-Positive Metastatic Colorectal Cancer (CRC) BRAFTOVI is indicated, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy [see Dosage and Administration (2.1) ] . 1.3 Limitations of Use BRAFTOVI is not indicated for treatment of patients with wild-type BRAF melanoma or wild-type BRAF CRC [see Warnings and Precautions (5.2) ] .

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