Advisory Panel Rejects New Use for Cancer Drug
顾问小组反对抗癌药物的新用途
A federal advisory committee voted yesterday that Genentech’s drug Avastin should not be approved as a treatment for breast cancer.
联邦顾问小组昨天投票决定反对Genentech公司的药物Avastin用于乳腺癌的治疗。
By a 5-4 vote, the committee decided that Avastin’s ability to delay the worsening of cancer did not outweigh the drug’s toxic side effects, especially since women getting Avastin did not live significantly longer in the end.
投票结果是5-4，委员会认为Avastin在推迟癌症恶化方面的作用不能超过它的毒负作用，特别是服用Avastin的妇女的寿命没有得到明显的延长。
“Absolutely it’s a very painful reality that metastatic breast cancer is not curable,” said Natalie Compagni Portis, a patient representative on the committee, who voted against an approval. But, she added, “I don’t think that means that we should just say, ‘Well, here, try this,’ if there isn’t meaningful data to support it.”
投了反对票的患者代表Natalie Compagni Portis女士说：“这是一个非常让人痛苦的事实—转移后的乳腺癌并没有被治愈；在缺乏有实质意义的数据来支持其疗效的情况下，我认为我们不应当对患者们说：喂，来，试试这个。”
Avastin is already on the market as a treatment for colon and lung cancer. The ultimate decision on whether to add an approval for breast cancer will be made by the Food and Drug Administration. But the agency usually adheres to the advice of its advisory committees.
Avastin已经被批准作为一种治疗结肠癌和肺癌的药物来使用。FDA将最终决定它是否可以作为一种治疗乳腺癌的药物来使用。但是FDA一般都会接受顾问小组的建议。
The vote was a rare setback for Genentech, widely considered the world’s most successful biotechnology company. The company’s stock plunged by 8 percent Wednesday, closing at $66.64.
Genentech被认为是世界上最成功的生物技术公司，这次的挫折对它而言是很罕见的。周三，公司的股票价格下跌了8%，收于66.64美元。
Although the F.D.A.’s staff had been critical of the drug in an analysis released on Monday, many Wall Street analysts had nevertheless thought the committee, made up mainly of cancer doctors, would vote in favor of approval.
虽然本周一F.D.A.的官员已经在一份分析中对这种药物提出了批评，但是一些华尔街的分析人士仍认为主要由癌症医生组成的顾问小组将投票赞成Avastin增加适应症。
Analysts were expecting an approval in breast cancer to add $1 billion or more to annual sales of the drug. Genentech’s stock has been steadily declining for the last two years because its once meteoric growth appears to be slowing.
分析人士预测如果Avastin被批准用于乳腺癌的治疗每年将增加10亿美元以上的销售额。Genentech公司的股票价格近两年一直在缓慢的下滑，因为它曾经飞快的增长速度已经减慢下来。
Avastin is already one of the world’s best-selling cancer drugs, with United States sales alone of $1.7 billion in the first nine months of this year.
Avastin已经是世界上最畅销的抗癌药物之一，在美国今年前九个月的销售额就达17亿美元。
Roche, which owns a majority of Genentech, sells the drug overseas. In Europe Avastin was approved for breast cancer based on the same clinical trial that failed to pass muster with the F.D.A. committee.
罗氏公司持有Genentech公司的大部分股份，在美国以外的市场销售Avastin。基于同样的临床实验数据（在F.D.A.委员会那里没有通过审批的数据），欧洲却批准Avastin用于乳腺癌的治疗。
The debate by the committee, which met in Gaithersburg, Md., reflected difficult questions that often surround cancer drugs, over how much benefit a drug needs to show before it can be approved.
委员会在Gaithersburg, Md.,开会时，内部也有争论，反映出困绕抗癌药物的一个问题即一种新药在它未获得审批之前应当表现出多大的益处。
The drug was being considered for approval as an initial treatment for women whose breast cancer had recurred or spread to other parts of the body. In the main clinical trial, women who got Avastin plus the generic cancer drug paclitaxel went a median of 11.3 months before their tumors worsened, compared with 5.8 months for women who received only paclitaxel.
FDA曾考虑将这种药作为一种治疗女性乳腺癌复发或者转移到身体的其他部分的初步处理药品来批准。在主要的临床实验中，女性患者将Avastin与另一种非专利抗癌药物paclitaxel共同使用，她们出现肿瘤恶化的中值是11.3个月，与此对比只使用paclitaxel的患者出现肿瘤恶化的中值是5.8个月
But the women who received Avastin did not live meaningfully longer. And they suffered more severe side effects, including five or six deaths out of 363 patients from the drug itself.
但是这不能证明服用Avastin使患者的生命得到了实质性的延长，而且她们遭受的负面影响更加严重，在363名患者中有5到6人因为药品本身的原因而死亡。
A big question for the committee was whether the delay in tumor worsening — a measure called progression-free survival — was really meaningful to patients, or whether it would be necessary to show that a drug lengthens life.
对委员会而言的一个大问题是这种对肿瘤恶化的推迟（衡量的标准是无进展生存周期）对患者是否有实质性的意义，或者说这种因药物而延长的生命时间对患者而言是否是绝对必要的。
Some oncologists on the panel argued that a delay of 5.5 months in progression would be meaningful because it might delay the onset of symptoms and relieve patients of anxiety.
They also said the progression-free survival was a more practical goal for a breast cancer trial. The effect of a drug on survival can be difficult to measure because patients take other drugs after the trial is over.
在顾问小组里一些肿瘤学家认为延长5.5个月的无进展生存周期是有意义的，因为它推迟了相关症状的发作，减轻了患者的焦虑。他们说无进展生存周期的延长对乳腺癌的临床试验而言是一个很实际的目标，至于这种药物对患者的负作用是很难衡量的，因为患者在临床试验中同样服用了其他药物。
“Many of my patients after their first-line approach go through five, six, seven, additional regimens,” said Dr. Gary H. Lyman, an oncologist at Duke University Medical Center who voted in favor of approval. “One has to wonder if the survival differences aren’t being clouded.”
杜克大学医学中心的肿瘤专家Gary H. Lyman博士（他投了赞成票）说：“我的许多患者在首选治疗手段之后还要经历5、6、7个额外的疗程。幸存患者的差别被抹杀是一件让人感到吃惊的事情。”
But others argued that progression-free survival is hard to measure. The radiologists who looked at X-rays to judge whether the cancer had worsened disagreed among themselves in about one-third of cases.
但是其他人认为无进展生存周期是很难衡量的。那些依据X射线来判断肿瘤是否恶化的放射专家内部对1/3的病例都有争议。
“You’ve not shown these patients are living better, and certainly they are not living longer,” said Dr. Maha Hussain, the committee’s chairwoman.
委员会的主席Maha Hussain博士说：“你们没有证据证明这些患者的生活水平改善了，而且她们的生命确实也没有得到实质性的延长。”
Dr. Hussain, a prostate cancer specialist at the University of Michigan, agreed that “patients are a nervous wreck when their disease is progressing, and that you have no tool to measure.” But she also said that women with breast cancer have many other drugs to choose from. She voted against Avastin.
密歇根大学的前列腺癌专家Hussain博士同意主席的观点：“当病情恶化时患者会出现精神衰弱，你也没有工具来衡量它。”她还说患有乳腺癌的女性还有很多其他的药品可供选择。
她因此投票反对批准Avastin.
Dr. Susan Desmond-Hellmann, Genentech’s president for product development, said the company might ask the F.D.A. for conditional approval on the promise of later providing survival data from two other clinical trials that are now under way.
Genentech公司的产品开发主席Susan Desmond-Hellmann博士说，公司将在另外两个正在进行的临床试验结束后收集有关患者的数据提供给FDA，并要求FDA有条件的批准Avastin用于治疗乳腺癌。
顾问小组反对抗癌药物的新用途
A federal advisory committee voted yesterday that Genentech’s drug Avastin should not be approved as a treatment for breast cancer.
联邦顾问小组昨天投票决定反对Genentech公司的药物Avastin用于乳腺癌的治疗。
By a 5-4 vote, the committee decided that Avastin’s ability to delay the worsening of cancer did not outweigh the drug’s toxic side effects, especially since women getting Avastin did not live significantly longer in the end.
投票结果是5-4，委员会认为Avastin在推迟癌症恶化方面的作用不能超过它的毒负作用，特别是服用Avastin的妇女的寿命没有得到明显的延长。
“Absolutely it’s a very painful reality that metastatic breast cancer is not curable,” said Natalie Compagni Portis, a patient representative on the committee, who voted against an approval. But, she added, “I don’t think that means that we should just say, ‘Well, here, try this,’ if there isn’t meaningful data to support it.”
投了反对票的患者代表Natalie Compagni Portis女士说：“这是一个非常让人痛苦的事实—转移后的乳腺癌并没有被治愈；在缺乏有实质意义的数据来支持其疗效的情况下，我认为我们不应当对患者们说：喂，来，试试这个。”
Avastin is already on the market as a treatment for colon and lung cancer. The ultimate decision on whether to add an approval for breast cancer will be made by the Food and Drug Administration. But the agency usually adheres to the advice of its advisory committees.
Avastin已经被批准作为一种治疗结肠癌和肺癌的药物来使用。FDA将最终决定它是否可以作为一种治疗乳腺癌的药物来使用。但是FDA一般都会接受顾问小组的建议。
The vote was a rare setback for Genentech, widely considered the world’s most successful biotechnology company. The company’s stock plunged by 8 percent Wednesday, closing at $66.64.
Genentech被认为是世界上最成功的生物技术公司，这次的挫折对它而言是很罕见的。周三，公司的股票价格下跌了8%，收于66.64美元。
Although the F.D.A.’s staff had been critical of the drug in an analysis released on Monday, many Wall Street analysts had nevertheless thought the committee, made up mainly of cancer doctors, would vote in favor of approval.
虽然本周一F.D.A.的官员已经在一份分析中对这种药物提出了批评，但是一些华尔街的分析人士仍认为主要由癌症医生组成的顾问小组将投票赞成Avastin增加适应症。
Analysts were expecting an approval in breast cancer to add $1 billion or more to annual sales of the drug. Genentech’s stock has been steadily declining for the last two years because its once meteoric growth appears to be slowing.
分析人士预测如果Avastin被批准用于乳腺癌的治疗每年将增加10亿美元以上的销售额。Genentech公司的股票价格近两年一直在缓慢的下滑，因为它曾经飞快的增长速度已经减慢下来。
Avastin is already one of the world’s best-selling cancer drugs, with United States sales alone of $1.7 billion in the first nine months of this year.
Avastin已经是世界上最畅销的抗癌药物之一，在美国今年前九个月的销售额就达17亿美元。
Roche, which owns a majority of Genentech, sells the drug overseas. In Europe Avastin was approved for breast cancer based on the same clinical trial that failed to pass muster with the F.D.A. committee.
罗氏公司持有Genentech公司的大部分股份，在美国以外的市场销售Avastin。基于同样的临床实验数据（在F.D.A.委员会那里没有通过审批的数据），欧洲却批准Avastin用于乳腺癌的治疗。
The debate by the committee, which met in Gaithersburg, Md., reflected difficult questions that often surround cancer drugs, over how much benefit a drug needs to show before it can be approved.
委员会在Gaithersburg, Md.,开会时，内部也有争论，反映出困绕抗癌药物的一个问题即一种新药在它未获得审批之前应当表现出多大的益处。
The drug was being considered for approval as an initial treatment for women whose breast cancer had recurred or spread to other parts of the body. In the main clinical trial, women who got Avastin plus the generic cancer drug paclitaxel went a median of 11.3 months before their tumors worsened, compared with 5.8 months for women who received only paclitaxel.
FDA曾考虑将这种药作为一种治疗女性乳腺癌复发或者转移到身体的其他部分的初步处理药品来批准。在主要的临床实验中，女性患者将Avastin与另一种非专利抗癌药物paclitaxel共同使用，她们出现肿瘤恶化的中值是11.3个月，与此对比只使用paclitaxel的患者出现肿瘤恶化的中值是5.8个月
But the women who received Avastin did not live meaningfully longer. And they suffered more severe side effects, including five or six deaths out of 363 patients from the drug itself.
但是这不能证明服用Avastin使患者的生命得到了实质性的延长，而且她们遭受的负面影响更加严重，在363名患者中有5到6人因为药品本身的原因而死亡。
A big question for the committee was whether the delay in tumor worsening — a measure called progression-free survival — was really meaningful to patients, or whether it would be necessary to show that a drug lengthens life.
对委员会而言的一个大问题是这种对肿瘤恶化的推迟（衡量的标准是无进展生存周期）对患者是否有实质性的意义，或者说这种因药物而延长的生命时间对患者而言是否是绝对必要的。
Some oncologists on the panel argued that a delay of 5.5 months in progression would be meaningful because it might delay the onset of symptoms and relieve patients of anxiety.
They also said the progression-free survival was a more practical goal for a breast cancer trial. The effect of a drug on survival can be difficult to measure because patients take other drugs after the trial is over.
在顾问小组里一些肿瘤学家认为延长5.5个月的无进展生存周期是有意义的，因为它推迟了相关症状的发作，减轻了患者的焦虑。他们说无进展生存周期的延长对乳腺癌的临床试验而言是一个很实际的目标，至于这种药物对患者的负作用是很难衡量的，因为患者在临床试验中同样服用了其他药物。
“Many of my patients after their first-line approach go through five, six, seven, additional regimens,” said Dr. Gary H. Lyman, an oncologist at Duke University Medical Center who voted in favor of approval. “One has to wonder if the survival differences aren’t being clouded.”
杜克大学医学中心的肿瘤专家Gary H. Lyman博士（他投了赞成票）说：“我的许多患者在首选治疗手段之后还要经历5、6、7个额外的疗程。幸存患者的差别被抹杀是一件让人感到吃惊的事情。”
But others argued that progression-free survival is hard to measure. The radiologists who looked at X-rays to judge whether the cancer had worsened disagreed among themselves in about one-third of cases.
但是其他人认为无进展生存周期是很难衡量的。那些依据X射线来判断肿瘤是否恶化的放射专家内部对1/3的病例都有争议。
“You’ve not shown these patients are living better, and certainly they are not living longer,” said Dr. Maha Hussain, the committee’s chairwoman.
委员会的主席Maha Hussain博士说：“你们没有证据证明这些患者的生活水平改善了，而且她们的生命确实也没有得到实质性的延长。”
Dr. Hussain, a prostate cancer specialist at the University of Michigan, agreed that “patients are a nervous wreck when their disease is progressing, and that you have no tool to measure.” But she also said that women with breast cancer have many other drugs to choose from. She voted against Avastin.
密歇根大学的前列腺癌专家Hussain博士同意主席的观点：“当病情恶化时患者会出现精神衰弱，你也没有工具来衡量它。”她还说患有乳腺癌的女性还有很多其他的药品可供选择。
她因此投票反对批准Avastin.
Dr. Susan Desmond-Hellmann, Genentech’s president for product development, said the company might ask the F.D.A. for conditional approval on the promise of later providing survival data from two other clinical trials that are now under way.
Genentech公司的产品开发主席Susan Desmond-Hellmann博士说，公司将在另外两个正在进行的临床试验结束后收集有关患者的数据提供给FDA，并要求FDA有条件的批准Avastin用于治疗乳腺癌。