ients received 20 mg/m2 at each dose in Cycle 1, and 27 mg/m2 in subsequent cycles. Dexamethasone 4 mg orally or intravenously was administered prior to Kyprolis doses in the first and second cycles.
A total of 70 patients were treated with this 20/27 mg/m2 regimen. Baseline patient and disease characteristics are summarized in Table 21.
Table 21: Demographics and Baseline Characteristics in Study 5 (20/27 mg/m2 Monotherapy Regimen for Relapsed or Refractory Multiple Myeloma)
FISH = Fluorescence in situ hybridization; ISS = International Staging System
Range: 1, 4.
Categories for refractory status are derived by programmatic assessment using available laboratory data.
Efficacy was eva luated by ORR as determined by IRC assessment using IMWG criteria. The median number of cycles started was seven. The ORR (PR or better) was 50% (95% CI: 38, 62) (see Table 22). The median DOR was not reached.
Table 22: Response Categories in Study 5 (20/27 mg/m2 Monotherapy Regimen)
CR = complete response; VGPR = very good partial response
Eligible patients had 1-3 prior lines of therapy and were refractory to the last regimen.
As assessed by an Independent Review Committee.
Exact confidence interval
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
Kyprolis (carfilzomib) is supplied as an individually cartoned single-dose vial containing a dose of 60 mg of carfilzomib as a white to off-white lyophilized cake or powder.
NDC 76075-101-01, 60 mg carfilzomib per vial
16.2 Storage and Handling
Unopened vials should be stored refrigerated (2°C to 8°C; 36°F to 46°F). Retain in original package to protect from light.
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ea66eb30-e665-4693-99a1-a9d3b4bbe2d6
欧盟CHMP支持批准安进抗癌药Kyprolis联合地塞米松二线治疗复发性多发性骨髓瘤
美国生物技术巨头安进（Amgen）抗癌管线近日在欧盟监管方面传来喜讯。欧洲药品管理局（EMA）人用医药产品委员会（CHMP）支持批准扩大Kyprolis（carfizomib）当前的适应症，纳入与地塞米松（dexamethasone）联合用药，用于既往已接受过至少一种疗法的多发性骨髓瘤（MM）成人患者。
CHMP的积极意见，是基于头对头III期ENDEAVOR研究的积极顶线数据。该研究中，Kyprolis一举击败多发性骨髓瘤（MM）临床首选药物——武田的万珂（Velcade，通用名：bortezomib，硼替佐米）。该研究在既往接受过至少一种但不超过3种方案治疗失败的MM患者中开展，数据显示，与Velcade联合地塞米松相比，Kyprolis联合地塞米松将病情恶化显著推迟一倍时间（中位无进展生存期（PFS）：18.7个月 vs 9.4个月；HR=0.53；95% CI:044,0.65，p＜0.0001）。此外，Kyprolis在总缓解率（ORR）及神经病变事件等次要终点方面，也表现出相对于Velcade的优越性。
值得一提的是，III期ENDEAVOR研究是安进针对武田Velcade精心设计的首个头对头研究。目前，一线治疗MM方面，安进正在推进另一个头对头III期研究，该研究正在初诊MM患者中开展，预计将在2016年获得数据。
在美国方面，今年1月，FDA批准Kyprolis联合地塞米松（dexamethasone）的组合疗法（Rd）以及联合Revlimid（lenalidomide，来那度胺）及地塞米松的组合疗法（KRd）用于既往已接受1-3线治疗的复发性或难治性多发性骨髓瘤（R/R MM）患者。此次Kyprolis令人垂涎的二线治疗，将为安进带来更庞大的患者群体，同时有望显著提升Kyprolis当前不甚理想的销售状况。
在欧洲，Kyprolis于2015年11月获批联合Revlimid及地塞米松的组合疗法（KRd），用于既往已接受过至少一种疗法的复发性多发性骨髓瘤成人患者。此次批准，使Kyprolis成为欧盟批准纳入组合疗法治疗复发性多发性骨髓瘤的首个不可逆蛋白酶抑制剂。
多发性骨髓瘤（MM）是第二种最常见的血液癌症，无法治愈且复发率很高。武田抗癌药Velcade是过去11年中唯一被证明能够延长初诊和复发性多发性骨髓瘤生存期的药物，已用作临床首选药物并在多发性骨髓瘤的临床治疗中发挥了重要作用. |
