FDA OKs Pfizer's Inlyta and accepts NDA for bosutinib

The US Food and Drug Administration on Friday approved global pharma behemoth Pfizer’s (NYSE: PFE) Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

“This is the seventh drug that has been approved for the treatment of metastatic or advanced kidney cell cancer since 2005,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, adding: “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.”

Recently approved drugs for the treatment of kidney cancer, the FDA noted, include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009). Pfizer said the average monthly cost of Inlyta is less than $8,900, which is generally consistent with other drugs approved for advanced kidney cancer, according to a Reuters report. Sales of Inlyta are forecast to reach $555 million in 2016, according to the average estimate of three analysts compiled by Bloomberg.