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Roche May Face Long Odds Getting FDA Cancer Drug Reversal

Avastin Showdown Pits Roche Against FDA Before Jury
After deliberations, the panel will make recommendations to FDA Commissioner Margaret Hamburg. Photo: Saul Loeb/AFP/Getty Images

Roche Holding AG may face long odds convincing a U.S. advisory panel to let the company’s top-selling drug Avastin be used against breast cancer.

The company is making its case tomorrow and Wednesday in appealing the Food and Drug Administration’s Dec. 16 decision to withdraw Avastin’s conditional approval in breast cancer after follow-up studies failed to show the drug produced enough benefit. The case is unusual because FDA rejections and appeals focus on failed treatments, not drugs that don’t live up to the agency’s expectations, said Ed Lang, a Roche spokesman.

The FDA’s decision probably cost the Swiss drugmaker $1 billion in sales, about half from the U.S., according to Michael Leacock, an analyst at Royal Bank of Scotland. An agency reversal to keep allowing Avastin sales for breast cancer with a warning would probably let them recover “a few hundred million francs” in sales, he said.

“We’ve made the assumption, perhaps harshly, that Avastin is not used in metastatic breast cancer” based on the FDA maintaining its position, Leacock said in a telephone interview from London. “Anything other than the FDA sticking to its guns would be a benefit to our Roche view.”

The FDA could keep the drug available with a warning while Roche conducts another study to prove its benefit in a group of patients, Leacock said. The agency will consider new evidence that concentrations of a protein in the blood may help identify patients whose health would most benefit from the treatment.

Unusual Proceeding

Six outside advisers to the FDA on cancer drugs are scheduled to vote at this week’s hearing, five of whom voted against Avastin in breast cancer last year. The panel’s patient representative, Natalie Portis, is the only one who also participated in a 2007 hearing, where she said the data didn’t support approval.

Roche petitioned unsuccessfully to get a new panel for Avastin. Karen Midthun, head of the FDA’s center for biologic drugs and the presiding officer at the hearing, told the company in March that the regulations required the use of the advisory committee at the hearing, though some members have rotated off since the earlier meetings on Avastin in breast cancer.

The unusual proceeding will feature testimony from expert witnesses for the FDA and Roche and cross-examination from lawyers. After the deliberations, the panel will make recommendations to FDA Commissioner Margaret Hamburg.

“We don’t view this as a courtroom,” said Karen Riley, a spokeswoman for the FDA, in a telephone interview. The recommendations aren’t binding and there’s no timeline for Hamburg to make any final ruling, Riley said.

Two Rejections

Doctors and scientists on the advisory panel have twice voted against approving Avastin for breast cancer. The panel will be asked this time to decide whether the studies used as the basis for its December recommendation fail to verify Avastin’s benefit in breast cancer, and if the drug is safe and effective.

Avastin had global sales of 6.46 billion Swiss francs last year ($6.22 billion), or 14 percent of Roche’s revenue. The drug is also approved for kidney, colon, lung and brain tumors.

Leacock stripped $1 billion from his Avastin peak sales estimate after the FDA proposed to withdraw approval in breast cancer. While European regulators opted to allow further marketing of Avastin, the FDA scrutiny and unprecedented debate has raised concern among doctors around the world, he said.

Roche, based in Basel, Switzerland, has little precedent to use in preparing its challenge, said Lang, the company spokesman.

2008 Decision

The FDA gave Avastin accelerated approval in breast cancer in February 2008 over the objections of its advisory panel. While the panel voted 5-4 that the data were mixed, the agency focused on one study that suggested the drug slowed disease progression.

Two required follow-up trials showed Avastin didn’t improve symptoms or help patients live longer, and it had a smaller effect on tumor growth. The panel met again in July 2010 and voted 12-1 that approval should be withdrawn.

Recent data suggest higher levels of a protein in blood known as VEGF-A may help identify patients who may derive substantial benefit from Avastin, according to Roche. The company is still working on the logistics of a new trial.

If the FDA upholds its policy and withdraws Avastin’s approval in breast cancer, conducting a study with the drug raises ethical concerns, Lang said.

“There is some suggestion that there might be patients who respond better to Avastin,” said Nicholas Turner, a London-based analyst for Mirabaud Securities, in a telephone interview. “If they can make that argument, there might be grounds for the drug to remain.”

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