Drug Detail

Information about Nexavar

Generic Name	Sorafenib
IND	BAY 43-9006
Brand Name (US)	Nexavar
Manufacturer	Bayer
Drug Type	Tyrosine Kinase Inhibitor
Delivery	Oral
Approval Status	Approved for a non-GIST cancer
Indications	Kidney cancer, liver cancer
Overall Strategy	GIST cell based
Strategy	Block KIT + Block KIT Signal Path
Drug Category	KIT/PDGFRA inhibitor+ VEGF inhibitor (TKI) + RAF inhibitor

Type: Oral

Approved for: Advanced Renal Cell Cancer (RCC) 12/20/2005, Unresectable Hepatocellular Carcinoma (HCC) 11/16/2007.

Targets: Sorafenib is a kinase inhibitor that decreases tumor cell proliferation in vitro. Sorafenib was shown to inhibit multiple intracellular (CRAF, BRAF and mutant BRAF) and cell surface kinases (KIT, FLT-3, RET, VEGFR-1, VEGFR-2, VEGFR-3, and PDGFR-ß).

Dosage: Per the FDA approved label, dosage is 400 mg (2 tablets) orally twice daily without food. Treatment interruption and/or dose reduction may be needed to manage suspected adverse drug reactions. Dose may be reduced to 400 mg once daily or to 400 mg every other day.

In the Phase II Trial in GIST, allowed dosing began with 400 mg taken twice daily. Reductions were allowed to 200 mg taken twice daily and 200 mg taken once daily. In the ASCO 2008 report on the Phase II trial, dose reductions were necessary in 59% of patients.

Side Effects: From the FDA approved label, the most common adverse reactions (≥20%), which were considered to be related to NEXAVAR, are fatigue, weight loss, rash/ desquamation, hand-foot skin reaction, alopecia, diarrhea, anorexia, nausea and abdominal pain.
Skin tumors have been noted in some patients taking Nexavar. Thus it has been recommended that patients receiving sorafenib or other RAF inhibitors should protect their skin from the sun.