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FDA批准pomalidomide治疗晚期多发性骨髓瘤

FDA approves pomalidomide for advanced multiple myeloma
来源:EGMN 2013-02-12 08:54点击次数:753发表评论

Pomalidomide已获准用于在接受了至少2种治疗(包括来那度胺和硼替佐米)之后仍然发生疾病进展,以及对治疗无应答且在最后一种治疗60天内发生疾病进展的多发性骨髓瘤患者的治疗。


“Pomalyst (pomalidomide)是继来那度胺和沙利度胺之后获准的第3种此类免疫调节药物,并且是过去1年来获准用于治疗多发性骨髓瘤的第2种药物。”美国食品药品管理局(FDA)药物评估与研究中心的血液与肿瘤产品办公室主任Richard Pazdur博士在声明中指出:“本次批准为其他药物无效的哈un这带来了新的治疗选择。”


Pomalidomide作为按孤儿药设计的药物,经过FDA加速批准程序获准上市,以便在生产商开展更多验证疗效与安全性的研究的同时,使患者能更早获得这种有希望的新药。


该药的安全性和有效性在一项纳入221例复发性或难治性多发性骨髓瘤患者的临床试验中得到了验证,入组患者随机接受pomalidomide单药治疗或pomalidomide+小剂量地塞米松治疗。结果显示,在接受pomalidomide单药治疗的患者中,7.4%产生了客观应答,应答维持的中位时间尚未达到。在接受pomalidomide+小剂量地塞米松治疗的患者中,29%产生了客观应答,应答维持的中位时间超过7个月。


常见副作用包括中性粒细胞减少、疲乏无力、贫血、便秘、腹泻、血小板减少、上呼吸道感染、背痛和发热。Pomalidomide附带一项加框警告,指出该药可引起血栓,并且由于可导致严重的、危及生命的出生缺陷而禁用于妊娠女性。


仅可通过Pomalyst风险评估与减缓策略(REMS)程序才能获得pomalidomide。来那度胺和沙利度胺也有相似的REMS。


Pomalidomide由Celgene公司销售。


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By: MARY JO DALES, Internal Medicine News Digital Network


Pomalidomide has been approved for the treatment of patients with multiple myeloma whose disease has progressed after treatment with at least two prior therapies, including lenalidomide and bortezomib, and whose disease did not respond to treatment and progressed within 60 days of the last treatment.


"Pomalyst (pomalidomide) is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide, and is the second drug approved in the past year to treat multiple myeloma," Dr. Richard Pazdur, director of the office of hematology and oncology products at the Food and Drug Administration’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval provides an additional treatment option for patients who have not responded to other drugs,"


Pomalidomide was granted orphan product designation and was approved under the agency’s accelerated approval program, which provides patients earlier access to promising new drugs while the company conducts additional studies to confirm the drug’s clinical benefit and safe use.


The drug’s safety and effectiveness was evaluated in a clinical trial of 221 patients with relapsed or refractory multiple myeloma randomly assigned to receive pomalidomide alone or pomalidomide and low-dose dexamethasone.


Among patients treated with pomalidomide alone, 7.4% achieved an objective response rate. The median duration of response has not yet been reached in these patients. In patients treated with pomalidomide plus low-dose dexamethasone, 29% achieved an objective response rate with a median duration of response exceeding 7 months.


Common side effects include neutropenia, fatigue and weakness, anemia, constipation, diarrhea, thrombocytopenia, upper respiratory tract infections, back pain, and fever.


Pomalidomide carries a boxed warning that the drug can cause blood clots and should not be used in pregnant women because it can cause severe life-threatening birth defects.


Pomalidomide is available only through the Pomalyst Risk Evaluation and Mitigation Strategy (REMS) Program. Prescribers must be certified with the Pomalyst REMS Program by enrolling and complying with the REMS requirements. Pharmacies must be certified with the Pomalyst REMS Program, must only dispense to patients who are authorized to receive the drug and must comply with REMS requirements. Both lenalidomide and thalidomide have similar REMS.


Pomalidomide is marketed by Celgene.


学科代码:肿瘤学 血液病学 药学   关键词:Pomalidomide 多发性骨髓瘤
来源: EGMN
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