Pfizer Drug Wins FDA Panel’s Backing for Pancreatic Cancer
Apple Inc. Ceo and Co-founder Steve Jobs
David Paul Morris/Bloomberg
Steve Jobs, chief executive officer and co-founder of Apple Inc.
Steve Jobs, chief executive officer and co-founder of Apple Inc. Photographer: David Paul Morris/Bloomberg
Pfizer Inc. (PFE) won a U.S. panel’s backing to expand marketing of a cancer drug for patients with the rare type of pancreatic tumor diagnosed in Apple Inc. (AAPL)’s Steve Jobs in 2004.
The medicine, Sutent, works sufficiently to outweigh potential risks, outside advisers to the Food and Drug Administration said today in an 8-2 vote in White Oak, Maryland. The panel concluded earlier today that Swiss drugmaker Novartis AG (NVS)’s Afinitor is effective for the same illness. The FDA usually follows its advisory committees’ recommendations.
Pfizer, based in New York, and Novartis want to sell their kidney-cancer drugs for pancreatic neuroendocrine tumors that strike about 2,500 people a year in the U.S., according to the University of Southern California Center for Pancreatic and Biliary Diseases in Los Angeles. Both medicines, which target cancer at the molecular level, helped slow progression of the disease in clinical trials.
“There is a benefit that we can’t really determine the magnitude of,” panel member Ralph Freedman, a professor of gynecologic oncology at the University of Texas MD Anderson Cancer Center in Houston, said after voting in favor of Pfizer’s drug. “On the other hand, this is a rare disease and there is an unmet need here.”
Attacking Tumors
Sutent, approved by the FDA in 2006 for stomach and kidney cancer, attacks tumors by cutting off their blood supply. European regulators approved the medicine in December for pancreatic neuroendocrine tumors that have spread. Sales of Sutent rose 11 percent last year to almost $1.1 billion, according to company filings.
Pfizer lost 21 cents, or 1 percent, to $20.46 at 4 p.m. in New York Stock Exchange composite trading. Novartis’s American depositary receipts, each representing one ordinary share, gained 7 cents to $55.26.
Sutent slowed tumor growth in a clinical study that may have overstated efficacy because initial success prompted investigators to end the trial early, FDA staff said April 8 in a preliminary review on the agency’s website.
The Pfizer study of 171 patients found that tumor progression stalled for a median time of 11.4 months in patients treated with Sutent, compared with 5.5 months for those taking a placebo.
Pfizer announced in March 2009 that it had stopped the study early, on the recommendation of an independent monitoring committee, because it would have been unethical to keep some patients on the placebo after Sutent showed a “significant benefit.”
Study Ended Early
While FDA staff agreed that Sutent stalled pancreatic neuroendocrine tumor progression five to six months longer than a placebo, they found that “the effect size is likely an overestimate due to multiple looks at the data and early termination of the study,” according to the staff report.
Jobs, the 56-year-old co-founder of Cupertino, California- based Apple, disclosed in 2004 that he’d had successful surgery to extract a pancreatic neuroendocrine tumor. He took another leave of absence in 2009 for a liver transplant, sometimes done when the cancer spreads.
Jobs hasn’t said whether the transplant was done to treat a recurrence of the tumor, and didn’t say on Jan. 17 why he was taking a third medical leave.
Novartis, based in Basel, Switzerland, won FDA approval for Afinitor in 2009 to treat patients with advanced kidney cancer who didn’t benefit from Sutent or Nexavar from Bayer AG (BAYN) and Onyx Pharmaceuticals Inc. (ONXX) Afinitor blocks a protein known as mTOR that some cancer cells require to grow and multiply. The drug is also used at a lower dose to prevent rejection of organ transplants. Revenue from the medicine more than tripled last year to $243 million.
Progression-Free Survival
Afinitor increased the time patients in a trial lived without pancreatic neuroendocrine tumors spreading, FDA staff said April 8 in asking the panel to evaluate the drug’s safety and efficacy. The company’s research had “discordant” data, the agency reviewers said in a report.
The FDA cited an inability of Novartis’ pancreatic study, and its separate trial on patients with similar tumors in other organs, “to support each other.” Afinitor’s efficacy was hard to assess in people with neuroendocrine tumors of the lung or gastrointestinal organs, partly because of imaging difficulties and “missing scans,” the agency said.
Novartis said April 8 that it had modified its FDA application so the expanded use of Afinitor, if approved, would apply only to tumors that originate in the pancreas. The company had previously sought to also market the drug to patients whose neuroendocrine cancer starts in the lungs, stomach or intestines.
A study of 410 patients, funded by Novartis and published Feb. 10 in the New England Journal of Medicine, found that people who took Afinitor lived for 11 months without their advanced tumors spreading, compared with 4.6 months for those taking a placebo.
To contact the reporter on this story: Molly Peterson in Washington at mpeterson9@bloomberg.net
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net
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