Yesterday, a US Food and Drug Administration panel voted 6-0 to recommend overturning the approval of Avastin to treat breast cancer. The drug was given accelerated approval in February 2008 after an initial trial indicated that it helped patients live longer. Since then, however, four subsequent trials have failed to confirm these early results, and last December the FDA proposed withdrawing the drug for breast cancer. Genentech appealed this decision in January.

The agency has already green-lighted Avastin to treat other cancers. The drug can extend the lives of people fighting colon and non-small-cell lung cancers. And even though it does not do the same for glioblastoma patients, it helps alleviate symptoms of the disease, which convinced regulators that it would be worth approving for this indication. “We felt very comfortable that the risk was worth it,” Wyndham Wilson, head of lymphoma therapeutics at the US National Cancer Institute in Bethesda, Maryland and chair of the FDA’s oncology drugs advisory committee, told Nature Medicine.

If Avastin trials had shown benefit in either area — lifespan or symptoms — for breast cancer, his committee may have recommended differently, Wilson says. At the hearing, patients testified that the drug helps, but the overall picture is that “Avastin is not bringing meaningful clinical benefit to women with untreated metastatic breast cancer,” he explains.

The story is not over yet: A final decision is expected from FDA Commissioner Margaret Hamburg next month. And Genentech plans to go ahead with an additional trial to study the drug’s effects when given with a different variety of chemotherapy.

Some scientists, meanwhile, foresee a time when doctors can better predict which breast cancer patients will actually respond positively to Avastin. “As a breast cancer oncologist, I sincerely believe in coming years we will be using Avastin in metastatic breast cancer once science has revealed which minority or subsets truly do benefit from it,” says Gary Lyman, an oncologist at the Duke University Medical Center in Durham, North Carolina who sat on earlier advisory committees regarding the drug.

On 25 May — just as the deadliest outbreak of Escherichia coli on record was beginning to tear through Germany — a team of physicians happened to publish an experimental therapy that could save lives in future outbreaks of this kind. The article, published online in the New England Journal of Medicine, described how an antibody therapy called Soliris (eculizumab) had successfully reversed the kidney damage and neurological symptoms seen in three young E. coli–infected children suffering from hemolytic-uremic syndrome (HUS), a deadly complication also seen in many victims of the German outbreak.

Soliris has been on the market since 2007 to treat a rare blood disorder called paroxysmal nocturnal hemoglobinuria, and it costs a staggering $400,000 per year. The antibody’s manufacturer, Connecticut-based Alexion Pharmaceuticals, had been testing Soliris in people who develop HUS without any E. coli infection. It filed for regulatory approval for this indication in the US and Europe earlier this year and reported further positive clinical trial data at this month’s Congress of the European Hematology Association in London.

But spurred by requests from German physicians after the findings related to E. coli–induced HUS came out, starting on 30 May, Alexion worked with health authorities in Germany to dispense the drug on a compassionate-use basis at no charge.

Since then, doctors across the country have administered Soliris to hundreds of those affected by the outbreak. And yesterday, Alexion formally launched an open-label clinical trial in people sickened by E. coli who have received Soliris during the crisis. “A clinical trial is the best environment to ensure that the drug is administered in a controlled manner to support safety and potential efficacy,” says Irving Adler, an Alexion spokesperson. But, according to Franz Schaefer, the lead author of the initial study and a nephrologist at the Center for Pediatrics and Adolescent Medicine in Heidelberg, Germany, the numbers coming in suggest that not everyone has responded as well as the kids in his team’s study. “The response, as far as I’ve heard, is kind of mixed,” he says.

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Witnessing the regulatory process surrounding the use of Genentech’s Avastin for treating breast cancer has been like watching a dramatic and slow motion game of tug-of-war. In 2007, a US Food and Drug Administration (FDA) advisory panel narrowly voted down the drug, citing a handful of deaths in the company’s pivotal trials due to side effects alone. Then, less than a year later, the agency granted Avastin an accelerated approval after new trial data showed that the drug added 5.5 months of progression-free survival compared to treatment with chemotherapy alone.

But after two more trials showed that patients do not live longer despite the breast cancer’s slowed spread and given Avastin’s somewhat nasty toxicity profile, an FDA advisory committee voted 12-1 last summer to pull the $100,000-a-year drug from the pharmacy shelf — a decision that Genentech appealed in January. Now, a meeting slated for next week will determine the drug’s fate.

The whole kerfuffle has caused uproar on each side of the spectrum. In a New York Times Op-Ed last month, Frederick Tucker, an oncologist in Fredericksburg, Virginia, supported the FDA’s decision, arguing that Genentech’s reinterpretation of its own data is troubling. Regarding patient testimonies, he wrote: “[A]necdote is not science. Such testimonials may represent the human voices behind the statistics, but the sad fact is that there are too many patients who have been treated with Avastin but are not here to tell their stories.”

On the other end are patients and their families who have had success with the drug. For example, Terrance Kalley, the husband of a breast cancer survivor who says she was saved by Avastin, took leave from his small Troy, Michigan automotive tools company to found the Freedom of Access to Medicines campaign, an effort to fight for access to the drug. The organization’s website lists testimonials, has a petition to sign and even a countdown timer to next week’s hearings.

Most recently, Kalley enlisted an anonymous compadre to record a Bob Dylan-esque protest song that has been making the rounds on Youtube. Decked out in a cargo vest in front of a faded American flag, the crooner sings: “They said it was too risky all of a sudden / They said it was kinda dangerous / Like having stage 4 breast cancer isn’t a jump through hell without a parachute.”

We’ll find out next week if the times for Avastin are a-changed.