Inlyta: VEGF-targeted treatment for refractory renal cell carcinoma

Inlyta (axitinib) is a new treatment for advanced renal cell carcinoma unresponsive to sunitinib or a cytokine.

The recommended starting dose of axitinib is 5 mg twice daily, which is adjusted according to safety and tolerability
The recommended starting dose of axitinib is 5 mg twice daily, which is adjusted according to safety and tolerability


Axitinib is a tyrosine kinase inhibitor of vascular endothelial growth factor receptors 1, 2 and 3. These receptors play a role in pathological angiogenesis, tumour growth and the metastatic progression of cancer.1


The safety and efficacy of axitinib were assessed in a pivotal phase III trial (AXIS) involving 723 patients with advanced renal cell carcinoma. Patients were randomised to receive either axitinib (n=361) or sorafenib (n=362) and evaluated for disease progression by investigator-blinded radiological assessment.2

In the intention-to-treat analysis, axitinib significantly extended progression-free survival (PFS) with a median average PFS of 6.7 months (95% CI 6.3–8.6) compared with 4.7 months (95% CI 4.6–5.6) for patients treated with sofarenib [HR=0.67, 95% CI 0.54–0.81; p<0.0001]. The objective response rate was 19% for axitinib and 9% for sorafenib (p=0.0001).2

The most common (≥20%) adverse effects observed with axitinib were diarrhoea, hypertension, fatigue, dysphonia, nausea, decreased appetite and hand–foot syndrome.1


  1. Inlyta Summary of Product Characteristics, September 2012.
  2. Rini BI et al. Lancet 2011; 378: 1931–9.

View Inlyta drug record
Further information: Pfizer

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