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FDA panel votes in favor of Pfizer kidney cancer drug

Oncologic Advisory Committee votes 13-0 in favor of axitinib's benefit-risk profile

NEW YORK — A Food and Drug Administration panel of 13 advisers has voted in favor of a drug made by Pfizer for treating kidney cancer, the drug maker said Wednesday.

Pfizer announced that the FDA's Oncologic Drugs Advisory Committee voted unanimously to state that axitinib's benefits outweighed its risks in patients with advanced renal cell carcinoma for whom first-line treatments had failed.

"We are pleased with the panel's recommendation in support of axitinib for the treatment of previously treated advanced RCC, as additional therapeutic options are still needed for this patient population," Pfizer Oncology Business Unit SVP clinical development and medical affairs Mace Rothenberg said. "We look forward to continued discussions with the FDA as we take the next steps in the regulatory process for axitinib."

The FDA is not bound by advisory committee votes when it decides whether or not to approve a drug, but takes them into account and usually makes its decisions in accordance with them.


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