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FDA Moves Pfizer Drug a Step Closer to Approval

FDA moves Pfizer drug a step closer to approval [The Day, New London, Conn.]

From Day, The (New London, CT) (December 8, 2011)


Dec. 08--A panel of the U.S. Food and Drug Administration unanimously has recommended the approval of Pfizer Inc.'s drug axitinib for use in kidney-cancer patients, the company announced Wednesday.

The FDA's Oncologic Drugs Advisory Panel voted 13-0 in support of using axitinib for treating patients with advanced renal cell carcinoma after failure of front-line therapy. The unanimous decision likely will mean a favorable ruling by the FDA when it votes on whether to approve marketing of the drug in the United States, but it doesn't guarantee FDA approval.

Pfizer's stock price reacted positively to the news, finishing the day at $20.47 a share. That's up 24 cents, or nearly 1.2 percent.

"We are pleased with the panel's recommendation ... as additional therapeutic options are still needed for this patient population," Mace Rothenberg, senior vice president of clinical development and medical affairs for Pfizer's Oncology Business Unit, said in a statement.

The form of kidney cancer targeted by axitinib, which came out of Pfizer's cancer research center in La Jolla, Calif., but was developed in part by scientists in Groton, affects about 58,000 new patients in the United States every year. More than 10,000 of the patients receiving initial diagnoses already are in advanced stages of the disease, and about 13,000 people die from the condition every year.

Pfizer previously had announced that axitinib showed significant effects in extending patient survival. The drug kept tumors at bay for 6.7 months, compared with a more established treatment that gave patients only 4.7 months of relief.

According to, the FDA panel's chairman, Wyndham Wilson, a leader at the National Cancer Institute's Center for Cancer Research in Rockville, Md, said axitinib "offers an important or useful alternative" to other kidney cancer treatments.

But the panel of outside experts said axitinib had a decided advantage in patients taking older cancer medications, while those on newer therapies such as Pfizer's drug Sutent saw only a small delay in tumor growth compared with Bayer's cancer treatment Nexavar, according to Bloomberg.


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Posted: December 2011