FDA approves axitinib to treat renal cell carcinoma

January 31, 2012

FDA approved axitinib (Inlyta, Pfizer) to treat patients with an advanced kidney cancer called renal cell carcinoma who have not responded to another drug for this type of cancer.

FDA approved axitinib (Inlyta, Pfizer) to treat patients with an advanced kidney cancer called renal cell carcinoma (RCC) who have not responded to another drug for this type of cancer.

RCC is a type of kidney cancer that starts in the lining of very small tubes in the kidney. Inlyta works by blocking certain proteins called kinases that play a role in tumor growth and cancer progression. It is a tablet that patients take twice a day.

Approximately 13,000 people die of advanced RCC in the United States each year, according to a Pfizer press release. Approximately 60,000 new cases of this tumor are diagnosed in the United States annually, about 20% of which have advanced disease at the time of diagnosis. Between 40% and 65% of patients who progress following first-line therapy go on to receive a second-line treatment.

“Axitinib is the first kidney cancer drug to be exclusively tested in a second-line setting and the first to compare itself against another targeted therapy,” Brian I. Rini, MD, Taussig Cancer Institute at Cleveland Clinic, told Drug Topics. “It has demonstrated robust results in terms of response rate and progression-free survival, and adds another treatment option for refractory patients.”

According to Rini, who served as principal investigator of the Pfizer-sponsored study and is a paid consultant to Pfizer Oncology, there are 2 clinical trials of axitinib in previously-untreated metastatic RCC patients “which will provide further insight into the clinical potency of this agent.”

Recently approved drugs for the treatment of kidney cancer include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009), and pazopanib (2009).

The safety and effectiveness of Inlyta were evaluated in a single randomized, open-label, multicenter clinical study of 723 patients whose disease had progressed on or after treatment with 1 prior systemic therapy. The study was designed to measure progression-free survival, the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib).

The most common side effects observed in greater than 20% of patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia), and constipation.

Patients with high blood pressure should have it well-controlled before taking Inlyta. Some patients who took the drug experienced bleeding problems, which in some cases were fatal. Patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.