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FDA approves axitinib for renal cell carcinoma
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The FDA today approved axitinib tablets for use in patients with previously treated advanced renal cell carcinoma.
The FDA approved axitinib (Inlyta, Pfizer) based on a single international, randomized, open-label trial involving patients with advanced renal cell carcinoma after failure of one prior systemic regimen.
Researchers evaluated 723 patients who were randomly assigned to receive axitinib 5 mg orally twice daily (n=361) or sorafenib 400 mg orally twice daily (n=362). Patients continued in their treatment until disease progression, the point of unacceptable toxicity or consent withdrawal. Enrollment criteria included an ECOG performance status of 0 or 1 and at least one prior systemic therapy that consisted one of the following treatments: sunitinib, temsirolimus, bevacizumab or cytokine(s).
Patients in the axitinib group demonstrated significantly extended PFS (HR=0.67; 95% CI, 0.54-0.81, P<.0001), with a median PFS of 6.7 months (95% CI, 6.3-8.6) compared with 4.7 months (95% CI, 4.6-5.6) for patients in the sorafenib group. That represented a 43% improvement in median PFS compared with sorafenib.
The most common adverse reactions (≥20% of patients) in the axitinib-treated group were diarrhea, diminished appetite, hypertension, fatigue, constipation, palmar-plantar erythrodysesthesia syndrome, nausea, dysphonia, weight loss, vomiting and asthenia. Other severe adverse reactions reported were hypertensive crisis, hemorrhage, gastrointestinal perforation and fistula formation, arterial and venous thrombotic events, and reversible posterior leukoencephalopathy syndrome.
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