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【drug-news】FDA批准Istodax用于治疗皮肤T细胞淋巴瘤

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FDA Approves Drug Treatment for Rare Cancer
Cutaneous T-cell lymphoma affects about 1,500 Americans annually

（Nov. 9, 2009）The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).

Cutaneous T-cell lymphoma is a slow-growing cancer of infection-fighting white blood cells called T-lymphocytes. Most cases start with dry skin, red rash, and itching that can become severe. The skin may develop tumors that can become ulcerated, causing infection. In some cases, CTCL spreads to the blood, lymph nodes, or internal organs. There are about 1,500 new cases of CTCL every year in the United States.

Patients with localized CTCL on the skin are treated with topical agents or phototherapy, but chemotherapy may be used if the cancer advances.

Istodax interferes with processes required for cell replication. It is intended to be used in patients when CTCL gets worse or comes back after at least one other type of chemotherapy has been used.

“This approval demonstrates FDA’s commitment to the development and approval of drugs for rare and uncommon diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. The FDA approved Istodax on Nov. 6, 2009.

Previous approvals for CTCL included Zolinza (vorinostat), Ontak (denileukin difitox), and Targretin (bexarotene).

Istodax was evaluated based on two clinical studies involving a total of 167 patients. About 35 percent of patients in both of the trials experienced tumor responses, indicating a reduction of the size of tumors. Responses lasted a median of 15 months in one study and 11 months in the other study. Six percent of those studied had complete responses, indicating no apparent evidence of the tumor on physical, laboratory, and X-ray examinations.

Common side effects include nausea, fatigue, infections, vomiting, decreased appetite, decreased red blood cell count, decreased platelet count, and decreases in the components of white blood cells.

Istodax may cause changes in an electrocardiogram (ECG). Periodic blood tests should be done to monitor electrolytes, and periodic ECG monitoring should be considered in patients at risk for certain heart rhythm abnormalities. Istodax may harm a fetus and women should not become pregnant while taking the drug.

Istodax is marketed by Gloucester Pharmaceuticals Inc. of Cambridge, Mass.

source:www.fda.gov

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2009-11-10 20:52

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初译：

FDA Approves Drug Treatment for Rare Cancer
Cutaneous T-cell lymphoma affects about 1,500 Americans annually
FDA批准新药用于治疗罕见癌症
皮肤T细胞淋巴瘤每年约影响1500个美国人

（Nov. 9, 2009）The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).
2009年11月9日，美国食品药品监督管理局（FDA）批准注射药物Istodax (romidepsin)用于治疗一种名为皮肤T细胞淋巴瘤（CTCL）的罕见癌症。

Cutaneous T-cell lymphoma is a slow-growing cancer of infection-fighting white blood cells called T-lymphocytes. Most cases start with dry skin, red rash, and itching that can become severe. The skin may develop tumors that can become ulcerated, causing infection. In some cases, CTCL spreads to the blood, lymph nodes, or internal organs. There are about 1,500 new cases of CTCL every year in the United States.
皮肤T细胞淋巴瘤是一种名为T-淋巴细胞的抗感染白细胞缓慢生长的癌症。大多数病例在开始时伴有皮肤干燥、红疹和瘙痒，并可能加重。可能发生肿瘤的皮肤会出现溃疡并引发感染。在一些病例中，CTCL可扩散至血液、淋巴结或内部器官。在美国，每年约有1500个新的CTCL病例。

Patients with localized CTCL on the skin are treated with topical agents or phototherapy, but chemotherapy may be used if the cancer advances.
伴有皮肤局部CTCL的患者可接受局部药物或光疗治疗，一旦病情恶化，则可能需要进行化疗。

Istodax interferes with processes required for cell replication. It is intended to be used in patients when CTCL gets worse or comes back after at least one other type of chemotherapy has been used.
Istodax可干扰细胞复制程序。该药被计划用于在已使用至少一种其他类型的化疗后病情仍趋于恶化或复发的CTCL患者。

“This approval demonstrates FDA’s commitment to the development and approval of drugs for rare and uncommon diseases,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. The FDA approved Istodax on Nov. 6, 2009.
FDA药物评估和研究中心的肿瘤药品办公室主任Richard Pazdur博士表示，“这次批准证明了FDA有关发展和批准用于治疗罕见和少见疾病药物的承诺。”FDA于2009年11月6日批准Istodax上市。

Previous approvals for CTCL included Zolinza (vorinostat), Ontak (denileukin difitox), and Targretin (bexarotene).
之前已批准用于治疗CTCL的药物包括Zolinza (vorinostat)、Ontak (denileukin difitox)和Targretin (bexarotene)。

Istodax was evaluated based on two clinical studies involving a total of 167 patients. About 35 percent of patients in both of the trials experienced tumor responses, indicating a reduction of the size of tumors. Responses lasted a median of 15 months in one study and 11 months in the other study. Six percent of those studied had complete responses, indicating no apparent evidence of the tumor on physical, laboratory, and X-ray examinations.
Istodax的评估是基于2项共纳入167名患者的临床研究。在这2项试验中约有35%的患者出现治疗反应，表现为肿瘤的大小减小。在其中1项研究中，治疗反应的持续中位时间为15个月，另一项研究为11个月。研究中有6%的患者已完成治疗，并通过体格、实验室和X-射线检查未发现肿瘤迹象。

Common side effects include nausea, fatigue, infections, vomiting, decreased appetite, decreased red blood cell count, decreased platelet count, and decreases in the components of white blood cells.
常见副作用包括恶心、疲劳、感染、呕吐、食欲减退、血红细胞计数降低、血小板计数减少以及白细胞组成减少。

Istodax may cause changes in an electrocardiogram (ECG). Periodic blood tests should be done to monitor electrolytes, and periodic ECG monitoring should be considered in patients at risk for certain heart rhythm abnormalities. Istodax may harm a fetus and women should not become pregnant while taking the drug.
Istodax可能引起心电图（ECG）改变。在伴有某些心律异常风险的患者中应考虑做定期的血液检验以监测电解质，以及定期的ECG监测。

Istodax is marketed by Gloucester Pharmaceuticals Inc. of Cambridge, Mass.
Istodax由位于美国马萨诸塞州剑桥市的Gloucester制药公司销售。

整理：

FDA批准Istodax用于治疗皮肤T细胞淋巴瘤

2009年11月9日，美国食品药品监督管理局（FDA）批准注射药物Istodax (romidepsin)用于治疗一种名为皮肤T细胞淋巴瘤（CTCL）的罕见癌症。

皮肤T细胞淋巴瘤是一种名为T-淋巴细胞的抗感染白细胞缓慢生长的癌症。大多数病例在开始时伴有皮肤干燥、红疹和瘙痒，并可能加重。可能发生肿瘤的皮肤会出现溃疡并引发感染。在一些病例中，CTCL可扩散至血液、淋巴结或内部器官。在美国，每年约有1500个新的CTCL病例。伴有皮肤局部CTCL的患者可接受局部药物或光疗治疗，一旦病情恶化，则可能需要进行化疗。

Istodax可干扰细胞复制程序。该药被计划用于在已使用至少一种其他类型的化疗后病情仍趋于恶化或复发的CTCL患者。FDA药物评估和研究中心的肿瘤药品办公室主任Richard Pazdur博士表示，“这次批准证明了FDA有关发展和批准用于治疗罕见和少见疾病药物的承诺。”FDA于2009年11月6日批准Istodax上市。之前已批准用于治疗CTCL的药物包括Zolinza (vorinostat)、Ontak (denileukin difitox)和Targretin (bexarotene)。

Istodax的评估是基于2项共纳入167名患者的临床研究。在这2项试验中约有35%的患者出现治疗反应，表现为肿瘤的大小减小。在其中1项研究中，治疗反应的持续中位时间为15个月，另一项研究为11个月。研究中有6%的患者已完成治疗，并通过体格、实验室和X-射线检查未发现肿瘤迹象。

常见副作用包括恶心、疲劳、感染、呕吐、食欲减退、血红细胞计数降低、血小板计数减少以及白细胞组成减少。Istodax可能引起心电图（ECG）改变。在伴有某些心律异常风险的患者中应考虑做定期的血液检验以监测电解质，以及定期的ECG监测。Istodax由位于美国马萨诸塞州剑桥市的Gloucester制药公司销售。（丁香）

2009-11-10 20:53

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荆夫编辑于 2009-11-11 10:45

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2009-11-11 14:22

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