Recently U.S. Food and Drug Administration has approved INLYTA(R) axitinib, a kinase inhibitor, for the treatment of patients with advanced renal cell carcinoma (RCC) who have not responded to another drug for this type of cancer.
Renal cell carcinoma 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. Inlyta is a pill that patients take twice a day.
Recently, approved drugs for the treatment of kidney cancer include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009), which have improved the outlook for RCC (progression-free survival), although they have not yet demonstrated improved survival.
The safety and effectiveness of Inlyta was evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one 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 FDA approval of this new treatment represents a significant benefit for the many patients who are living with this type of kidney cancer and who are in need of additional treatment options," said William Bro, Chief Executive Officer of the Kidney Cancer Association.
“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” said Richard Pazdur, M.D, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. 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.” He added
Patients with high blood pressure should have it well-controlled before taking Inlyta. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal. Patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta.