Nexavar for Advanced RCC

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Nexavar Was the First Multiple Kinase Inhibitor Approved for the Treatment of Patients with Advanced RCC

Proven efficacy in the largest Phase 3 study for advanced RCC

The efficacy and safety of Nexavar was proven in the largest Phase 3, multi-center, randomized, double blind, placebo controlled trial conducted in advanced RCC. Nexavar was shown to significantly double progression-free survival (P<0.000001; HR: 0.44; 95% CI, 0.35-0.55), vs. placebo across all patient subsets. In a planned interim analysis, the rate of overall survival was longer with Nexavar than placebo with a hazard ratio of 0.72 based on 220 deaths (95% CI, 0.55-0.95).2 The analysis did not meet the pre-specified criteria for statistical significance. Nexavar was generally well tolerated with a predictable profile. The most common adverse events were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, and nausea/vomiting. Grade 3/4 adverse events were 38% for Nexavar vs. 28% for placebo.

Kinases are important anticancer targets

Kinases are specialized proteins that function within intracellular communication networks known as signal transduction pathways.3 In cancer, preclinical studies have shown that these pathways are important in the development of tumor vasculature and in the proliferation of tumor cells, leading to tumor growth and metastases. Therefore, by blocking the kinases involved in these signaling pathways, tumor growth and proliferation may be controlled.4

Kinases are located on multiple levels of signaling pathways. Receptor tyrosine kinases are located upstream in the signaling pathway of tumor vasculature (e.g., VEGFR and PDGFR) and tumor cells (e.g., KIT and FLT-3). Serine/threonine kinases are located downstream in the signaling pathway within the cells of tumors and tumor vasculature (e.g., RAF/MEK/ERK).4

Multiple Kinase inhibition is important to cancer treatment

Multiple kinase inhibition works at multiple levels of signaling pathways in tumor cells and tumor vasculature. For example, preclinical studies have shown that by providing upstream blockade of VEGF and PDGF receptors as well as downstream blockade of the RAF/MEK/ERK pathway, Nexavar simultaneously decreases both angiogenesis and tumor cell proliferation, which helps by blocking tumor growth.4


* In preclinical models.


Next: TARGET Phase 3 Clinical Trial Design & Results
 
Term
Explanation for term.

Indications and Usage


Nexavar is indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC) and for the treatment of patients with advanced renal cell carcinoma (RCC)

Important Safety Considerations


Hypertension may occur early in the course of treatment. Monitor blood pressure weekly during the first 6 weeks and periodically thereafter and treat, as required.

An increased risk of bleeding may occur following Nexavar administration. If bleeding necessitates medical intervention, consider discontinuation of Nexavar.

Cardiac ischemia and/or myocardial infarction may occur. Temporary or permanent discontinuation of Nexavar should be considered in patients who develop cardiac ischemia and/or myocardial infarction.

Gastrointestinal perforation was an uncommon adverse reaction and has been reported in less than 1% of patients taking Nexavar.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in unresectable HCC, respectively, were: diarrhea (55% vs 25%), fatigue (46% vs 45%), abdominal pain (31% vs 26%), weight loss (30% vs 10%), anorexia (29% vs 18%), nausea (24% vs 20%), and hand-foot skin reaction (21% vs 3%). Grade 3/4 adverse reactions were 45% vs 32%.

Most common adverse reactions reported for Nexavar-treated patients vs placebo-treated patients in advanced RCC, respectively, were: diarrhea (43% vs 13%), rash/desquamation (40% vs 16%), fatigue (37% vs 28%), hand-foot skin reaction (30% vs 7%), alopecia (27% vs 3%),and nausea (23% vs 19%). Grade 3/4 adverse reactions were 38% vs 28%.

Hand-foot skin reaction and rash are common and management may include topical therapies for symptomatic relief. In cases of any severe or persistent adverse reactions, temporary treatment interruption, dose modification, or permanent discontinuation of Nexavar should be considered. Temporary interruption of Nexavar therapy is recommended in patients undergoing major surgical procedures.

Elevations in serum lipase and reductions in serum phosphate of unknown etiology have been associated with Nexavar. Caution is recommended when administering Nexavar with compounds that are metabolized/eliminated predominantly by the UGT1A9 pathway, UGT1A1 pathway (eg, irinotecan), doxorubicin, docetaxel, fluorouracil, and substrates of CYP2B6 and CYP2C8, and CYP3A4 inducers. Patients taking concomitant warfarin should be monitored regularly for changes in prothrombin time, INR, or clinical bleeding episodes.

Women of childbearing potential are advised to avoid becoming pregnant and against breastfeeding.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For important risk and use information, please see the full prescribing information.