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Campath-FDA批准治疗B细胞性慢性淋巴细胞性白血病新药(二)
2013-10-29 23:05:21 来源: 作者: 【 】 浏览:7488次 评论:0
patients. Results were determined by objective tumor response rates and duration of response, as defined by the NCI Working
Group Response Criteria.
In the largest of the three trials, an overall response rate of 33 percent was observed, with a median duration of seven months. A 30
percent mortality rate was
recorded, either during the study or within six months of its completion. Half of these deaths were due to progression of the disease,
while the other half were
 related to Campath therapy. Adverse events associated with Campath therapy included infusion-related events, infections, and hematological toxicity.
Side Effects
Adverse events associated with the use of Campath therapy may include (but are not limited to) the following:
Neurotropenia
· Fever and rigors
· Anemia
· Thrombocytopenia
· Sepsis
· Pneumonia
· Nausea
· Vomiting
· Rash
· Hypotension
 
Mechanism of Action
Campath (alemtuzumab) works by binding to the CD52 antigen that is present on the surface of the malignant lymphocytes. After
binding, the drug induces antibody-dependent lysis, or killing. This causes the removal of malignant lymphocytes from the blood, bone marrow, and other affected organs.
Additional Information
For additional information on Campath, please visit Campath.

FDA专题小组推荐Campath
2001/02/28
    美国FDA肿瘤药物顾问委员会已推荐Millenium Pharmaceuticals与Ilex Dncology公司的人化抗淋巴细胞单克隆抗体Campath(alemtuzumab)(Ⅰ)的加速批准,用于已用过烷化剂治疗和氟达拉滨(fludarabine)(Ⅱ)治疗无效的慢性淋巴 细胞性白血病(CLL)病人。
    专题小组会以14对1票通示(Ⅰ),其决定是依据一项关键的Ⅱ期试验和二项 以前的试验结果。在关键的93例病人的试验中,(Ⅰ)组有33%的病人有效,平均有效期为7个月。23%的病人的客观有效期一年多。
    FDA也要求Millenium作进一步试验或从目前的研究中搜寻更多的资料。如果 获批,(Ⅰ)将与(Ⅱ)在美国竞争,后者是Schering公司销售的,于1999年获准用于难治性CLL病人。
    在该关键性试验中,病人接受(Ⅰ)递增剂量以尽量减少输液引起的相关副作 用,达每周三次,每次30mg,共4~12周。平均存活时间16个月,比以前的对(Ⅱ) 治疗无效而用其它疗法的CCL病人研究所见到的3~10个月存活时间长些。但不是 所有的病人一样受益,FDA医药评审Genevieve Schechter说,研究6个月结束时, 已有28例死亡,30例因感染、血液学毒性反应或输液相关/反应而中止治疗,还有67%有严重的不良反应。
    约30%的病人有3级或4级的机会性感染,其中23例是肺炎。其他感染是系列感染、脓毒症、巨细胞病毒与疱疹。副作用有发热、赛战、恶心呕吐与皮疹,与每周三次的二小时输液相关,见于90%的病人。
    (Ⅰ)的半衰期较长,故其已知的免疫抑制与血液学毒性等副作用也较持久,对严重的白血病患者增加了危险。然而,只有一项对比性试验可能确定是(Ⅰ)或基础疾病导致死亡及不良反应。所有病人都是重病人,因过去用过(Ⅱ)故在试验 之前即有广泛的免疫抑制。

Campath(ALEMTUZUMAB)英文说明书 
 
Package Insert
Campath® (ALEMTUZUMAB)
Millennium and ILEX Partners, LP
Table of Contents
Description
Clinical Pharmacology
Clinical Studies
Indications and Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage and Administration
How Supplied
 
WARNING Campath should be administered under the supervision of a physician experienced in the use of antineoplastic therapy. · Hematologic Toxicity: Serious and, in rare instances fatal, pancytopenia/ marrow hypoplasia, autoimmune idiopathic thrombocytopenia, and autoimmune hemolytic anemia have occurred in patients receiving Campath therapy. Single doses of Campath greater than 30 mg or cumulative doses greater than 90 mg per week should not be administered because these doses are associated with a higher incidence of pancytopenia. · Infusion Reactions: Campath can result in se

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