Inlyta Prescribing Information

(ChemotherapyAdvisor) – The U.S. Food and Drug Administration (FDA) has approved the oral kinase inhibitor Inlyta (axitinib) for the treatment of patients with advanced renal cell carcinoma (RCC).

Approval was based on results of the open-label, multicenter, phase 3 AXIS trial, in which 723 patients with advanced RCC who had failed one prior systemic therapy were randomized to second-line axitinib 5mg orally twice daily or sorafenib 400mg orally twice daily.

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The primary efficacy end point was progression-free survival (PFS), as assessed by an Independent Review Committee consisting of two blinded radiologists. Median PFS was 6.7 months (95% CI 6.3–8.4) for axitinib and 4.7 months (95% CI 4.6–5.6) for sorafenib; the hazard ratio was 0.67 (95% CI 0.55–0.81).

The adverse events (AEs) observed with axitinib were comparable to agents in the same class of small molecule inhibitors of the VEGF pathway: diarrhea, nausea, fatigue, asthenia, hypertension, and hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, and constipation. Patients with hypertension should have it well-controlled before taking axitinib, the FDA noted.

Less common AEs included arterial and venous thrombotic events, gastrointestinal perforation, bleeding events, hypothyroidism, dysphonia, proteinuria, and reversible posterior leukoencephalopathy syndrome.

According to the FDA, axitinib is the seventh drug approved for the treatment of metastatic or advanced RCC since 2005. Others are sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009).

Axitinib is marketed by Pfizer, Inc.