Pfizer Inc won unanimous expert backing for its Inlyta experimental drug for patients with advanced kidney cancer.
A Food and Drug Administration advisory committee voted 13-0 on Wednesday that the drug, also called axitinib, had a favorable benefit-risk profile for such patients after initial treatment has failed.
The FDA, which usually approves products that win support from its advisory panels, is due to make a final decision in the first half of 2012.
Panelists said the oral drug was at least as safe and effective as previously-approved treatments for the disease, such as Nexavar, which is sold by Bayer AG and Onyx Pharmaceuticals Inc.
It also had different side effects than other drugs for the disease, which could be important for patients who cannot tolerate older treatments, said Dr. Wyndham Wilson, chair of the panel and chief of the lymphoma therapeutics section at the National Cancer Institute.
“It’s my take that the toxicity profile is different, there’s benefit there, and it’s not inferior to currently approved TKIs,” Dr. Wilson said, referring to drugs in the same class.
“If you have two drugs that are equivalently effective, … different toxicity profiles can be very useful for the individual,” he said.
About 61,000 Americans will be diagnosed with kidney cancer this year, and about one in five of them are expected to die from the disease, according to the American Cancer Society.
FDA staff said Pfizer’s kidney cancer drug showed the same degree of liver enzyme elevation and potential for liver failure as some other drugs in its class, but had lower rates of skin related side effects and anemia than Nexavar in a clinical trial.
Inlyta, which inhibits certain receptors that can influence tumor growth and progression of cancer, is one of several new drugs Pfizer is banking on to help replace lost revenue from its top-selling cholesterol fighter, Lipitor, which began facing generic competition last week.
Pfizer shares were up 1 percent at $20.43 in early afternoon trading on the New York Stock Exchange, slightly outperforming the wider Arca Pharmaceutical Index.
Inlyta is awaiting an approval decision in Europe for use in patients who failed to be helped by prior treatment.
The drug is also being tested in another late-stage trial for kidney cancer as both an initial treatment option and in previously treated patients. It is also being tested as a treatment for liver cancer.
(Reporting By Anna Yukhananov, Editing by Tim Dobbyn)
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By Anna Yukhananov
