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Advanced renal cell carcinoma: FDA approves Nexavar
The FDA ( U.S. Food and Drug Administration ) has approved Nexavar ( Sorafenib ) tablets for the treatment of patients with advanced renal cell carcinoma.
Nexavar, which has been shown to double progression-free survival in patients with advanced renal cell carcinoma, is the first FDA-approved treatment for this type of cancer in more than a decade.
Nexavar is the first oral multi-kinase inhibitor that targets serine/threonine and receptor tyrosine kinases in both the tumor cell and tumor vasculature.
In preclinical models, Nexavar targeted members of two classes of kinases known to be involved in both tumor cell proliferation and tumor angiogenesis.
These kinases included RAF kinase, VEGFR-2, VEGFR-3, PDGFR-B, KIT, and FLT-3.
Nexavar's FDA approval was based on Phase III data from the largest randomized, placebo-controlled trial ever conducted in patients with advanced renal cell cancer.
In the Phase III study, Nexavar doubled progression-free survival ( PFS ) when compared to placebo.
Progression-free survival measures the time that a patient lives without evident tumor growth. In this study, PFS was doubled to a median value of six months in patients receiving Nexavar as compared to three months for patients receiving placebo ( p-value < 0.000001 ).
All subgroups examined, including patients who had not received conventional treatment with biologics, such as Interleukin-2 or Interferon-alpha, appeared to benefit as well.
At the time of a planned interim survival analysis, based on 220 deaths, overall survival was longer for Nexavar than placebo with a hazard ratio ( Nexavar over placebo ) of 0.72.
This analysis did not meet the prespecified criteria for statistical significance. Additional analyses are planned at the time survival data mature.
In the pivotal Phase III trial, the most common reported treatment- emergent adverse events of any severity were diarrhea, rash/desquamation, fatigue, hand-foot skin reaction, alopecia, nausea, pruritus, hypertension, vomiting, and anorexia.
Grade 3 and 4 treatment-emergent adverse events were reported in 31 percent ( vs. 22 percent for placebo-treated patients ) and 7 percent ( vs. 6 percent for placebo-treated patients ) of Nexavar treated patients, respectively.
Nexavar has been studied in more than 20 tumor types and in more than 4,000 patients to date. It is currently in Phase III clinical trials for the treatment of advanced hepatocellular carcinoma ( HCC ), or liver cancer, and metastatic melanoma, or skin cancer.
A Phase III clinical trial in non-small cell lung cancer ( NSCLC ) is planned for the first half of 2006.
Important safety considerations
An increased risk of bleeding may occur following Nexavar administration. Patients taking concomitant warfarin should be monitored regularly.
The incidence of treatment-emergent cardiac ischemia/infarction events was higher in the Nexavar group ( 2.9 percent ) compared with the placebo group ( 0.4 percent ).
Blood pressure should be monitored weekly during the first six weeks of Nexavar therapy and managed throughout treatment.
In cases of severe or persistent side effects, temporary or permanent discontinuation of Nexavar should be considered.
Women of child-bearing potential should be advised to avoid becoming pregnant while on Nexavar.
