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【drug-news】专家披露: 为什么投票反对阿瓦斯丁乳
Breast Cancer Doc Explains His Vote Against Avastin
Posted by Jacob Goldstein
Why did an FDA advisory committee yesterday vote against approval of Avastin for advanced breast cancer? The Health Blog called Aman Buzdar, a breast cancer specialist at UT’s M.D. Anderson Cancer Center, to find out.
“On face value the data look very good,” said Buzdar, who voted with the slim (5-4) majority against the drug. In the study that was the basis of Genentech’s application, Avastin appeared to slow the progress of the disease.
But women who received the drug didn’t live longer than those who didn’t. Buzdar said that other drug combinations approved by FDA for similar patients do improve survival. His thinking was also influenced by an earlier study of Avastin in women with advanced breast cancer who had already tried other drugs. That study failed to meet its goal, which made Buzdar question the findings in the study Genentech did submit. “You wonder why the second study was positive and the first study was negative,” he told us.
He said he’s never used Avastin to treat breast cancer, but he knows other doctors do, despite the lack of FDA’s blessing. “Physicians always want to do something for the patient,” he said. But he believes the panel’s vote “will make them think twice” before they try Avastin for breast cancer.
“This drug is a good drug,” Buzdar added. “It does work in a number of other cancers where it not only prolongs control of the disease but it keeps more patients alive. In breast cancer, it has not panned out.”
Susan Desmond-Hellmann, Genentech’s president of product development, said company officials “remain convinced that Avastin is helpful for patients with metastatic breast cancer,” the WSJ reports. December 7, 2007, 8:52 am
Medicare to Cut Payment for Smart-Bomb Cancer Drugs
Posted by Jacob Goldstein
Medicare’s about to cut reimbursement rates for two lymphoma drugs, GlaxoSmithKline’s Bexxar and Biogen Idec’s Zevalin. The cuts may lead many hospitals to stop offering treatment with the drugs because they’d have to use them at a loss, the NYT reports this morning.
The drugs, known as radioimmunotherapies because they combine a radioactive molecule with an antibody, cost nearly $30,000 per patient, the companies say. Medicare says it will reimburse $16,000 per patient starting next year, which the government says is a fair price based on what hospitals have actually paid for the drugs this year.
The medicines are a drug-designer’s dream: the antibodies home in on cancer cells and kill them with a precise dose of radioactivity. Think smart bombs.
The planned cutback has riled up the the online lymphoma community. Google “radioimmunotherapy” and you’ll see an ad that sends you to the Leukemia and Lymphoma Society’s pre-written letter on the issue, asking the secretary of Health and Human Services to block the price cuts from taking effect.
Newsweek’s Jonathan Alter, himself a survivor of lymphoma (though not the form treated by these drugs) wrote a scathing column on the subject last month. Lymphoma bloggers are hitting the subject as well.
And the Lymphoma Research Foundation reported last week that the Senate Finance Committee is considering a provision that would keep radioimmunotherapy reimbursements at the same level next year. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 December 6, 2007, 1:47 pm
Breast Cancer Doc Explains His Vote Against Avastin
Posted by Jacob Goldstein
2007年12月6日，下午1时47分
乳腺癌医生解释为什么投票反对阿伐斯汀
Jacob Goldstein发布
Why did an FDA advisory committee yesterday vote against approval of Avastin for advanced breast cancer? The Health Blog called Aman Buzdar, a breast cancer specialist at UT’s M.D. Anderson Cancer Center, to find out.
为什么ＦＤＡ的咨询委员会昨天投票反对批准阿伐斯汀用于晚期乳癌治疗？健康博客邀请德克萨斯大学Anderson癌症中心乳腺癌专家Aman Buzdar帮我们找出答案。
“On face value the data look very good,” said Buzdar, who voted with the slim (5-4) majority against the drug. In the study that was the basis of Genentech’s application, Avastin appeared to slow the progress of the disease.
根据基因泰克应用阿伐斯汀的研究成果表明，它延缓了病情进展。他说：“数据的价值表面上看起来非常好。”Buzdar是投票反对（5-4）阿伐斯汀的大多数成员中的一分子。
But women who received the drug didn’t live longer than those who didn’t. Buzdar said that other drug combinations approved by FDA for similar patients do improve survival. His thinking was also influenced by an earlier study of Avastin in women with advanced breast cancer who had already tried other drugs. That study failed to meet its goal, which made Buzdar question the findings in the study Genentech did submit. “You wonder why the second study was positive and the first study was negative,” he told us.
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作者:admin@医学,生命科学 2011-02-28 05:11
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