Pfizer Inc. (PFE), the world’s biggest drugmaker, won a U.S. panel’s backing for an experimental medicine for advanced kidney cancer in patients who have failed prior treatments.
The benefits of the drug, known as axitinib, outweigh its risks, 13 outside advisers to the Food and Drug Administration said today in a unanimous vote in Silver Spring, Maryland. The FDA isn’t required to follow advisory panels’ recommendations.
The medicine from New York-based Pfizer may compete with Aveo Pharmaceuticals Inc. (AVEO)’s tivozanib, a kidney-cancer drug in late-stage clinical trials. Both treatments block receptors in the body thought to play a role in spreading tumors. Kidney cancer affects 296,000 people in the U.S., according to the American Cancer Society.
“It met the regulatory bar” for approval “and offers an important or useful alternative” to approved treatments, said Wyndham Wilson, the panel chairman, who is chief of lymphoma therapeutics at the National Cancer Institute’s Center for Cancer Research, in Rockville, Maryland.
Pfizer gained 1.2 percent to $20.47 at the close in New York. The shares have increased 17 percent this year.
Sales of axitinib, if approved, may reach $576 million in 2014, according to the average estimate of three analysts surveyed by Bloomberg. Pfizer is seeking to sell the treatment under the name Inlyta.
“We are pleased with the panel’s recommendation in support of axitinib for the treatment of previously treated advanced renal cell carcinoma, as additional therapeutic options are still needed for this patient population,” Mace Rothenberg, senior vice president of clinical development and medical affairs at Pfizer, said in an e-mail after the vote.
FDA staff reviewers questioned the significance of efficacy data in a trial that compared axitinib with kidney-cancer drug Nexavar from German drugmaker Bayer AG. In the study of 723 patients who had failed one prior therapy, those treated with axitinib lived a median of 6.7 months before their tumors got worse, two months longer than those who received Nexavar, agency staff said in a Dec. 5 report.
That two-month benefit was “driven by a subset of patients that is likely to be scarce in the United States,” the reviewers said.
Axitinib was most effective in people previously treated with cytokines, immune-boosting drugs that aren’t as widely used as newer therapies such Pfizer’s Sutent. Patients in the cytokine group who received axitinib lived a median of 5.6 months longer without tumor progression than those in that group who were treated with Nexavar, agency reviewers said.
Axitinib’s benefits were “meager” in the larger group of patients treated previously with Sutent, delaying tumor growth just 1.4 months longer than Nexavar did, according to the report.
The FDA’s concerns about axitinib may have “positive implications” for the competing drug being developed by Cambridge, Massachusetts-based Aveo, said Thomas Wei, an analyst at Jefferies & Co. in New York.
“We remain bullish on the prospects for tivozanib to become the standard of care in the first-line treatment of renal cell carcinoma,” Wei said Dec. 5 in a note to clients.
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