FDA Logo Renal cell carcinoma is a kind of kidney cancer that begins in the lining of extremely small tubes in the kidney. More recently, the US Food and Drug Administration (FDA) has approved the drug namely Inlyta for the treatment of patients suffering from advanced kidney cancer who are non-responsive to other medications for this cancer.

To test the working and safety of the drug, a randomized trial constituting nearly 723 patients whose condition had advanced and were exposed to 1 prior systematic therapy, was conducted. The team wished to examine if the drug helped in progression free survival, which is the period when the disease does not progress and the patient is alive.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005. Collectively, this unprecedented level of drug development within this time period has significantly altered the treatment paradigm of metastatic kidney cancer, and offers patients multiple treatment options,” commented Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

While a standard treatment using a sorafenib resulted in 4.7 months progression free survival, Inlyta apparently showed 6.7 months progression-free survival. The common side-effects seen were high blood pressure, loss of voice, poor appetite, hand-foot syndrome, diarrhea, weakness, nausea, vomiting, weight loss, tiredness and constipation.

As a word of caution, the team has urged patients to control high blood pressure prior to consuming Inlyta. Notably, patients with gastrointestinal bleeding and untreated brain tumors should not consume this drug. Some of the individuals who took the medication also seemed to encounter bleeding problems that turned fatal in some cases.

Inlyta is a tablet that is supposed to be taken 2 times in a day. It is marketed by Pfizer.