2012年7月20日美国食品药品监督管理局(FDA批准Kyprolis(carfilzomib)治疗多发性骨髓瘤曾接收至少两种既往治疗，包括治疗用万珂Velcade (硼替佐米[bortezomib])和一种免疫调节治疗的患者。
一种来源于浆细胞的血癌形式，多发性骨髓瘤通常在骨髓中生长，在骨中发现的软，海绵组织。骨髓是正常血细胞生产的地方。按美国癌症学会估计在2012，21,700人将被诊断有多发性骨髓瘤而10,710人将死于这种疾病。
FDA的药物评价和研究中心血液学和肿瘤室主任Richard Pazdur，M.D 说：“Kyprolis的批准对尽管使用可得到的治疗其疾病已进展的多发性骨髓瘤患者提供治疗选择，”“在过去十年通过为多发性骨髓瘤药物不断的进展，提供这种疾病改善治疗。我们受到鼓舞。”
在266例复发多发性骨髓瘤曾接收至少两种既往治疗，包括万珂和Thalomid (沙利度胺[thalidomide])患者的一项研究评价患者静脉直接给予Kyprolis的安全性和有效性。
研究被设计成测量后治疗患者经历肿瘤完全或部分消失(总缓解率)的患者比例。总缓解率为23%。中位缓解时间是7.8 个月。
观察到最常见副作用，多于30%研究参加者是疲乏，血细胞计数和血血小板水平低，气短，腹泻，和发热。用Kyprolis见到的严重副作用包括心衰和气短。如果发生这些严重副作用应密切监视患者和中止治疗。
在FDA的加速批准计划下批准药物，允许监督管理局批准药物治疗一种严重疾病根据临床资料显示该药物对某个替代性终点有效，是有理由预测对患者临床获益。这个程序被设计提供患者更早得到鼓舞人新药。公司被要求在批准后提交另外临床信息证实药物的临床获益。
批准日期:2012年7月20日；公司： Onyx Pharmaceuticals, Inc
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use KYPROLIS safely and effectively. See full prescribing information for KYPROLIS.
KYPROLIS ® (carfilzomib) for injection, for intravenous use
Initial U.S. Approval: 2012
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Kyprolis is a proteasome inhibitor that is indicated:
in combination with dexamethasone or with lenalidomide plus dexamethasone for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. (1, 14)
as a single agent for the treatment of patients with relapsed or refractory multiple myeloma who have received one or more lines of therapy. (1, 14)
DOSAGE AND ADMINISTRATION
See Full Prescribing Information for dosing.
Hydrate prior to and following Kyprolis administration as needed. (2.1)
Premedicate Kyprolis infusions with dexamethasone prior to all Cycle 1 doses and if infusion reaction symptoms develop or reappear. (2.1)
Administer the 20/56 mg/m2 regimen by 30-minute infusion and the 20/27 mg/m2 regimen by 10-minute infusion. (2.2)
DOSAGE FORMS AND STRENGTHS
For injection: 60 mg, lyophilized powder in single-dose vial for reconstitution (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
Cardiac Toxicities: Monitor for signs and symptoms of cardiac failure or ischemia. Withhold Kyprolis and eva luate promptly. (5.1)
Acute Renal Failure: Monitor serum creatinine regularly. (5.2)
Tumor Lysis Syndrome (TLS): Administer pre-treatment hydration. (2.1) Monitor for TLS, including uric acid levels and treat promptly. (5.3)
Pulmonary Toxicity, including Acute Respiratory Distress Syndrome, Acute Respiratory Failure, and Acute Diffuse Infiltrative Pulmonary Disease: Withhold Kyprolis and eva luate promptly. (5.4)
Pulmonary Hypertension: Withhold Kyprolis and eva luate. (5.5)
Dyspnea: For severe or life threatening dyspnea, withhold Kyprolis and eva luate. (5.6)
Hypertension Including Hypertensive Crisis: Monitor blood pressure regularly. If hypertension cannot be controlled, interrupt treatment with Kyprolis. (5.7)
Venous Thrombosis: Thromboprophylaxis is recommended. (5.8)
Infusion Reactions: Premedicate with dexamethasone. (2.1, 5.9)
Thrombocytopenia: Monitor platelet counts; interrupt or reduce Kyprolis dosing as clinically indicated. (2.3, 5.10)
Hepatic Toxicity and Hepatic Failure: Monitor liver enzymes regularly. Withhold Kyprolis if suspected. (5.11)
Thrombotic M |
