Bayer and Onyx drug approved in kidney cancer

Nexavar, which has been shown to double progression-free survival in patients with advanced RCC, is the first FDA-approved treatment for this type of cancer in more than a decade.

“Nexavar is an oral anticancer drug that blocks tumor growth in new ways,” said Arthur Higgins, chairman of Bayer HealthCare’s executive committee. “It has demonstrated the ability to prolong progression-free survival. Nexavar also has been shown to delay the progression of cancer in the majority of patients with a manageable side effect profile — an area that has been a challenge for patients and their physicians.”

Nexavar’s FDA approval was based on phase III data from the largest randomized, placebo-controlled trial ever conducted in patients with advanced renal cell cancer. In the study, Nexavar doubled progression-free survival when compared to placebo. All subgroups examined, including patients who had not received conventional treatment with biologics, such as interleukin-2 or interferon-alpha, appeared to benefit as well.