December 22, 2024

F.D.A. Approves a Drug for Hot Flashes

The first nonhormonal drug to treat hot flashes won approval from the Food and Drug Administration on Friday, offering a new alternative to menopausal women.

The move was surprising because an advisory committee to the F.D.A. voted 10 to 4 in March against approval.

The treatment, which will be called Brisdelle, was developed by Noven Pharmaceuticals and consists of a low dose of paroxetine, which is used at higher doses in the antidepressant Paxil.

Approved treatments for menopausal hot flashes until now have all contained the hormone estrogen, sometimes in combination with progestin. But hormone use has decreased sharply since a study in 2002 suggested that the combination of estrogen and progestin could increase the risk of cardiovascular problems and cancer.

“There are a significant number of women who suffer from hot flashes associated with menopause and who cannot or do not want to use hormonal treatments,” Dr. Hylton V. Joffe, director of the F.D.A’s division of bone, reproductive and urologic products, said in a statement.

While the F.D.A. does not have to follow the recommendations of its advisory panels, it is highly unusual for it to approve a drug that receives a strong negative vote. Committee members who voted against it said while there was a need for a nonhormonal therapy, Noven’s candidate was only minimally effective.

The agency did not explain why it went against the panel’s recommendation, saying only that it viewed Brisdelle as a useful treatment that had met its goals in clinical trials.

Women in the clinical trials for Brisdelle started out with a median of about 10 hot flash episodes a day. After 12 weeks, those who took the drug had a median of nearly six fewer episodes a day, compared with a reduction of four or five episodes a day for those receiving the placebo.

While the difference was statistically significant, many members of the advisory committee said such a difference would not be meaningful to women.

Noven, which is based in Miami and is a subsidiary of Hisamitsu Pharmaceutical of Japan, said Brisdelle would be available in November. It did not say how much the drug would cost.

Dr. Joel Lippman, chief medical officer of Noven, said in a statement that 24 million women in the United States had moderate to severe hot flashes and that two-thirds of them were not currently treating them.

Brisdelle’s label has a strong warning that the drug can increase suicidal thoughts or behavior, language similar to that on the labels of other drugs containing paroxetine. Other warnings include an increased risk of bleeding, and possible reduction in the effectiveness of the breast cancer drug tamoxifen if both drugs are used together.

The advisory panel in March gave an even stronger no vote to another proposed nonhormonal treatment for hot flashes, an extended-release version of the neurology drug gabapentin. In that case, the F.D.A. went along with the panel, rejecting the drug, according to an announcement by its developer, Depomed.

Article source: http://www.nytimes.com/2013/06/29/business/fda-approves-a-drug-for-hot-flashes.html?partner=rss&emc=rss

Prescriptions: F.D.A. Again Rejects Avastin for Breast Cancer

Updated:

An advisory committee to the Food and Drug Administration voted unanimously on Wednesday that the approval of Avastin as a treatment for breast cancer should be revoked, despite a two-day appeal hearing by Genentech, the drug’s manufacturer.

In four 6-0 votes, the committee said recent studies have not shown that the drug is safe and effective. It unanimously rejected a compromise proposal made by Genentech that the approval be retained while the company conducts another clinical trial to confirm that the drug works.

The votes make it more likely that the F.D.A. will go ahead with its decision, made in December, to rescind the approval. The actual decision will be made by the agency’s commissioner, Dr. Margaret A. Hamburg. It is not clear when the decision will be made but it will not be until after July 28 because the F.D.A. will still accept public comments until then.

The votes came after an emotional two-day hearing at the F.D.A. campus in Silver Spring, Md., in which about a dozen women with breast cancer, many of them saying that Avastin was helping control their disease, pleaded with the agency to make sure the drug remained available.

Even if the breast cancer approval is withdrawn, the drug will remain on the market as a treatment for other cancers, so doctors could use it “off label” to treat breast cancer. But insurers might be less likely to pay for the drug, which can cost $88,000 a year for a typical breast cancer patient.

Avastin received so-called accelerated approval for metastatic breast cancer in 2008 under a program that allows drugs for serious diseases to reach the market more quickly, subject to further study.

The F.D.A. said in December that these subsequent studies had not confirmed the initial findings, so it proposed to rescind the drug’s approval for breast cancer.

Neither of the two new studies showed that the drug prolonged women’s lives or improved the quality of their lives. And in the two new studies, use of the drug delayed the progression of tumors by less than one month to 2.9 months, far less than the 5.5-month delay seen in the initial trial.

Genentech argued that the new trials still showed that the drug had benefits, even if they were not as great as in the initial trial. Certainly, the company said, the new results did not contradict the results of the initial trial.

The company said that the difference in trial results might be explained by the different chemotherapy drugs with which Avastin was used. It is proposing to do another clinical trial combining Avastin with paclitaxel, the chemotherapy drug used in the initial trial that led to approval. In the meantime, it said, Avastin should retain its approval.

“The law provides this flexibility and this middle course best meets the purposes of accelerated approval to facilitate needed treatment options,” Michael S. Labson, a lawyer representing Genentech, said at the hearing.

Genentech said the trial would take several years to complete.

Article source: http://feeds.nytimes.com/click.phdo?i=2afac44b551c3f80ad6a79014be0fdea

Prescriptions: Cancer Survivors Appeal to F.D.A. Over Avastin

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