July 13, 2024

Breast Cancer Patients Plead for Avastin Approval

With desperate breast cancer patients imploring the Food and Drug Administration to change its mind, the agency’s staff calmly argued Tuesday that the drug Avastin should lose its approval as a treatment for that disease.

The pleas and presentations came on the first day of a two-day hearing at which Genentech, the manufacturer of Avastin, is getting a chance to try to persuade the F.D.A. to reverse its decision made in December to revoke the drug’s approval for advanced breast cancer.

The proceedings emphasized a conflict that has bedeviled pharmaceutical regulation and other efforts to control the practice of medicine — one between cold statistics from clinical trials about overall populations and the often emotional experiences of individual patients who say a therapy has, or might, work for them.

About a dozen women with breast cancer, some tearful, told the F.D.A. that while Avastin did not show a big benefit over all in clinical trials, the medicine did help some women substantially and should be left available for that reason.

“Despite the potential side effects from Avastin, metastatic breast cancer has only one — death,” Priscilla Howard, who said Avastin had controlled her cancer for 32 months, told the committee presiding over the hearing. “I want every available weapon in my arsenal as I fight this devastating disease.”

Avastin received so-called accelerated approval for metastatic breast cancer in 2008 under a system intended to allow drugs for serious diseases to get to market more rapidly, subject to later studies to confirm they really work.

The F.D.A. said that those subsequent studies had not confirmed that Avastin was safe and effective. With five randomized trials of Avastin now having been completed, the F.D.A. said, no trial had shown that Avastin prolonged life or improved the quality of life. And no trial showed that the drug delayed the progression of tumors to the same extent as the one trial that led to the drug’s approval.

“All we are asking for here is one trial that shows clinical benefit,” said Dr. Richard Pazdur, the head of the agency’s cancer drug division.

F.D.A. officials said that data from trials had not shown even a small subset of women receiving Avastin living substantially longer than those in the control group, raising doubts about whether there are “super responders” who derive great benefit from the drug.

“We’re just not seeing that population,” said Dr. Patricia Keegan, an official in the agency’s cancer drug division.

Even if the approval is revoked, Avastin would remain on the market as a treatment for other types of cancer, so doctors could use it off-label to treat breast cancer. However, insurers would be less likely to pay for the drug, which Genentech says costs a typical breast cancer patient $88,000 a year.

Women with breast cancer testifying at the hearing feared the drug would become out of reach for them and other cancer patients. Husbands, doctors and some patient advocates also spoke in favor. Each speech in favor of retaining Avastin’s approval was met by applause.

“Make no mistake, this hearing is a death trial, not of Avastin but of these women who rely on Avastin to stay alive,” said Terry Kalley, of Troy, Mich., whose wife, Arlene, is being treated with Avastin.

Mr. Kalley also helped organize a demonstration by women and their families that took place just outside the F.D.A. campus in Silver Spring, Md., where the hearing was held.

Representatives of advocacy groups for patients with ovarian, kidney and colon cancer and melanoma also spoke in favor of retaining the breast cancer approval, saying, among other things, that revocation could discourage drug development.

But defying the mood in the room, representatives of four breast cancer advocacy groups testified in favor of the F.D.A.’s proposal to withdraw the approval.

“What use is there for a drug which in this population has more toxicities, some very serious, than the previous standard of care?” said Helen Schiff of Share, a breast and ovarian cancer support group.

Ms. Schiff said that for every woman who testified Tuesday in favor of Avastin, there were others who were not helped by the drug or had even been hurt by side effects like brain hemorrhages.

“Those people don’t come to testify,” she said.

Christine Brunswick, representing the National Breast Cancer Coalition, said: “The F.D.A.’s decision on Avastin must be based on scientific evidence from well-done trials and cannot be based on any one individual story, no matter how compelling.”

These remarks were met by derision. “I am completely disgusted to have to follow somebody like that,” said Kim Jewett, a breast cancer patient and representative of mylifeline.org, a cancer support group, who spoke directly after Ms. Brunswick.

Genentech, which is owned by Roche, will present its case on Wednesday. Later that day, the advisory committee will vote on its recommendations for the F.D.A. commissioner, Dr. Margaret A. Hamburg, who will make the decision at some future time.

Article source: http://feeds.nytimes.com/click.phdo?i=306cd771a7de763415fa32d3c43d8b46

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