Pfizer Wins U.S. FDA Approval for Advanced Kidney-Cancer Treatment Inlyta

Pfizer Inc. (PFE), the world’s biggest drugmaker, won U.S. clearance to sell a new medicine for advanced kidney cancer in patients who have failed prior treatments.

The Food and Drug Administration approved the drug, Inlyta, after concluding it helps prevent the cancer from progressing, the agency said today in a statement.

The drug will provide a new treatment option for as many as 13,000 patients diagnosed with advanced kidney cancer in the U.S. each year, said Subramanian Hariharan, the lead of New York-based Pfizer’s global medical team for Inlyta. Sales of the drug may reach $555 million in 2016, according to the average estimate of three analysts compiled by Bloomberg.

“We’re excited for patients,” Hariharan said today in an interview. “Along with Sutent and Torisel, Pfizer now has three drugs that will help physicians and patients with advanced kidney cancer in the United States.”

Pfizer declined less than 1 percent to $21.48 at the close in New York. The shares have gained 16 percent in the past year.

Inlyta, Sutent and Torisel are among seven drugs approved by the FDA for metastatic or advanced kidney cancer since 2005, Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, said in the statement. The others are Nexavar from Bayer AG (BAYN) and Onyx Pharmaceuticals Inc. (ONXX), Novartis AG (NOVN)’s Afinitor, Roche Holding AG (ROG)’s Avastin and GlaxoSmithKline Plc (GSK)’s Votrient.

Potential Competitor

Tivozanib, a kidney-cancer drug from Cambridge, Massachusetts-based Aveo Pharmaceuticals Inc. (AVEO) is in late-stage clinical trials and may also compete with Inlyta if it gains FDA approval.

Inlyta, known chemically as axitinib, worked better than Nexavar in a comparative study of 723 patients who had failed one prior therapy. Those treated with Inlyta lived a median of 6.7 months before their tumors got worse, two months longer than patients who received Nexavar, the FDA said.

Pfizer’s drug also shrunk tumors in 19 percent of the trial participants who received it, compared with 9 percent of patients treated with Nexavar, Hariharan said.

Inlyta blocks 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.

To contact the reporter on this story: Molly Peterson in Washington at

To contact the editor responsible for this story: Adriel Bettelheim at

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