Generic Name and Formulations:
Pomalidomide 1mg, 2mg, 3mg, 4mg; capsules.
美国食品药品管理局（FDA）2月8日批准Pomalyst (pomalidomide)用于其它癌症药物治疗后病情仍有进展的多发性骨髓瘤患者的治疗。
多发性骨髓瘤起因于骨髓中的浆细胞，属血癌的一种，主要影响老年人有。根据美国国家癌症研究所提供的信息，每年大约有21700名美国人被诊断为多发性骨髓瘤，并且会有10710人死于该种疾病。
Pomalyst通过调节人体免疫系统破坏癌细胞，抑制癌细胞的生长。该药物用于先前至少接受过包括来那度胺和硼替佐米在内的两种药物治疗的患者，，患者已对药物没有响应，并在60天的治疗期内病情仍有发展（复发和难以治疗）。
“Pomalyst是包括来那度胺和沙利度胺在内的第三个免疫调节剂类药物， 也是过去一年来第二个被批准用于治疗多发性骨髓瘤的药物，” FDA药物评价和研究中心血液和肿瘤产品办公室主任Richard Pazdur医学博士说。“对于多发性骨髓瘤的治疗要通过调整以满足个体患者的要求，今天Pomalyst的获批给对其它药物不起响应的患者提供了另一种治疗选择。”

2012年7月，FDA批准Kyprolis(carfilzomib)用于治疗多发性骨髓瘤。和Kyprolis情况类似，Pomalyst也是通过FDA加速审评程序而获得批准，这样可以使患者早日用到这个比较有希望的药物，同时公司要进行额外的研究以确保该药物的临床收益和安全使用。另外该药物由于其用途是治疗罕有疾病而获得了孤儿药资格。
Pomalyst的安全性和有效性通过221名复发或难治性多发性骨髓瘤患者参与的临床试验进行评价。临床试验的目的是检测使用该药物治疗之后（目标反应率，或ORR），癌症完全或部分消失的患者数量。
结果显示，单纯使用Pomalyst治疗的患者目标反应率为7.4%。但患者对该药物的持续响应时间仍未达到中位值。Pomalyst加低剂量地塞米松治疗的患者目标反应率为29.2%，平均响应时间为7.4个月。
Pomalyst有一个黑框警告，提醒患者和医护专业人员该药不能用于孕妇，因为该药物能引起严重致命性的出生缺陷，另外该药物还能引起血血栓。
由于Pomalyst的胚胎-胎儿风险，该药物只能通过Pomalyst风险评估与控制策略(REMS)程序才能使用。该药物处方必须进行登记并符合风险评估与控制策略的要求，且需通过Pomalyst REMS鉴定。患者必须签有医患协议并遵守REMS的要求。特别指出的是没有怀孕但能成为孕妇的女性患者必须进行妊娠检查并采取避孕措施，男性必须遵守避孕要求。药房必须通过Pomalyst REMS程序认证，必须把药物配发给获得授权可以使用该药物的患者，必须遵守REMS要求。来那度胺和沙利度胺也有类似的REMS。
该药物常见的副作用包括能使抗击感染的白细胞减少（嗜中性粒细胞减少症）、疲劳和虚弱、红细胞计数降低（贫血）、便秘、腹泻、血小板计数降低（血小板减少症）、上呼吸道感染、背部疼痛和发烧。
Pomalyst、来那度胺和沙利度胺均由新泽西州Summit的塞尔基因公司上市销售，Kyprolis由加利福尼亚州南旧金山的奥尼克斯制药公司上市销售。  

Company:
Celgene Corp
Indications for POMALYST:
Multiple myeloma, in patients who have received at least two prior therapies (including lenalidomide and bortezomib), and have shown disease progression on or within 60 days of completion of the last therapy. Clinical benefit, such as improvement in survival or symptoms, has not been verified.

Adult Dose for POMALYST:
Swallow whole; may be taken with water. Take without food. 4mg once daily on Days 1–21 of repeated 28-day cycles until disease progression; may give with dexamethasone. Dose modification for hematologic and other Grade 3/4 toxicities: see full labeling.

Children's Dose for POMALYST:
<18yrs: not established.

Pharmacological Class:
Immunomodulator.

Rems:
YES

Contraindications:
Pregnancy (Cat. X): avoid during and for at least 4 weeks after completing therapy.

Warnings/Precautions:
Females of reproductive potential must commit either to abstain from heterosexual sex or to use two methods of reliable contraception, beginning 4 weeks prior to initiating, during therapy, dose interruptions and for 4 weeks after discontinuation. Obtain two negative pregnancy tests prior to initiating therapy: perform first test within 10–14 days, and second test within 24 hours prior to prescribing, and then weekly during first month, then monthly thereafter in women with regular menstrual cycles or every 2 weeks if irregular cycles. Males: must use latex or synthetic condom during therapy and up to 28 days after discontinuing, even after successful vasectomy; do not donate sperm. Patients must not donate blood during therapy and for 1 month after discontinuation. Venous thromboembolism; consider anticoagulation prophylaxis. Monitor for hematologic toxicities (esp. neutropenia); obtain CBCs weekly for first 8 weeks and monthly thereafter; may need dose interruption and/or modification. Renal impairment (serum creatinine >3mg/dL) or hepatic impairment (serum bilirubin >2mg/dL and AST/ALT >3x ULN): avoid. Risk of hypersensitivity or second primary malignancies. Nursing mothers: not recommended.

Interactions:
May be potentiated by strong CYP1A2, CYP3A (eg, ketoconazole), or P-gp inhibitors; avoid. May be antagonized by strong CYP1A2, CYP3A (eg, rifampin), or P-gp inducers; avoid. Smoking may reduce efficacy.

Adverse Reactions:
Fatigue, asthenia, neutropenia, anemia, constipation, nausea, diarrhea, dyspnea, upper-respiratory tract infections, back pain, pyrexia; venous thromboembolism, dizziness, confusion, neuropathy, pneumonia, thrombocytopenia.

Note:
Note: Available only through Pomalyst REMS program.

Generic Availability:
NO

How Supplied:
Caps—21, 100