About a dozen women with breast cancer, some tearful, beseeched the Food and Drug Administration on Tuesday to retain the approval of the drug Avastin as a treatment for the disease.
Testifying at a hearing at the F.D.A., the women said that although clinical trials might not have shown a huge benefit overall from treatment with the drug, the medicine does help some women substantially and should be left available for them.
“I’m not just a statistic; it’s in your hands to make sure I do not become one,’’ said Patricia Howard, who received her first Avastin treatment at 2007 in New York. “Due to Avastin, I am experiencing a quality of life that is nothing short of miraculous.’’
The hearing is being held Tuesday and Wednesday to give Genentech, the drug’s manufacturer, a chance to persuade the agency to back down from a tentative decision made in December to revoke the approval of Avastin as a therapy for breast cancer.
Avastin received so-called “accelerated approval” for metastatic breast cancer in 2008 under a system designed 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. says that in the case of Avastin, those subsequent studies did not confirm that Avastin was safe and effective.
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.
The turnout Tuesday at the hearing in Silver Spring, Md., was in sharp contrast to a paltry showing last July, when an F.D.A. advisory committee first met to consider whether to withdraw the approval.
At that meeting, only one woman – the same Ms. Howard – testified in favor of retaining the approval. The advisory panel voted 12 to 1 that the approval should be rescinded.
On Tuesday, about 10 women with breast cancer spoke in favor of Avastin in front of the same advisory committee. Some also demonstrated outside the hearing. 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 Terrance D. Kalley, of Troy, Mich., whose wife, Arlene, is being treated with Avastin and who helped organized Tuesday’s protest. “A vote against Avastin by each of you is a vote against thousands of women.”
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 that in this population does not extend life and has significant toxicities?’’ 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 such side effects as brain hemorrhages.
“Those people don’t come to testify,” she said. “I just want you to remember they exist.”
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 someone like that,’’ said Kimberley Jewett, a breast cancer patient and representative of mylifeline.org, a cancer support group, who spoke directly after Ms. Brunswick.
The public testimony, with each speaker given three minutes, occupied the first two hours of the two-day hearing. The rest of the time, Genentech, which is owned by Roche, and the F.D.A.’s drug division will present their competing views and scientific evidence for why the approval should be retained or withdrawn.
On Wednesday, the advisory committee will vote on certain questions that will serve as 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=24debf7372c18bffec73d77ee5b4ce98
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