2012年10月12日，Celgene宣布美国食品药品管理局(FDA)已批准Abraxane(注射用白蛋白结合型紫杉醇悬液)与卡铂联用，作为不适宜接受根治性手术或放疗的局部晚期或转移性非小细胞肺癌(NSCLC)患者的一线治疗。这一批准令标志着Abraxane在美国获得了第二种适应证。该药之前已于2005年获准用于治疗联合化疗失败的转移性乳腺癌。
Abraxane的本次获准是基于一项3期、多中心、随机、开放标记研究的结果。在该研究中，晚期NSCLC患者接受Abraxane(100 mg/m2)/周+卡铂每3周1次(n=521)，或紫杉醇(200 mg/m2)每3周1次+卡铂(n=531)治疗。这项研究达到了其主要终点，表明Abraxane组患者的总应答率显著高于紫杉醇组(33% vs. 25%)。
与Abraxane联合卡铂治疗NSCLC有关的最常见不良反应包括，贫血、中性粒细胞减少、血小板减少、脱发、周围神经病变、恶心和疲乏。
在Abraxane+卡铂治疗组和紫杉醇+卡铂治疗组患者中发生率相似的不良反应包括：脱发56%，恶心27%，疲乏25%，食欲不振17%，无力16%，便秘16%，腹泻15%，呕吐12%，呼吸困难12%，以及皮疹10%(以上均为Abraxane+卡铂治疗组的发生率)。
ST LOUIS (MD Consult) - On October 12, 2012, Celgene announced that the US Food and Drug Administration has approved Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. This approval marks the second indication for Abraxane in the United States. The drug was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy.
This Abraxane approval was granted on the basis of results a phase 3, multicenter, randomized, open-label study where patients with advanced NSCLC received either Abraxane (100 mg/m2) weekly plus carboplatin every 3 weeks (n = 521) or paclitaxel (200 mg/m2) every 3 weeks plus carboplatin (n = 531). The study met its primary end point demonstrating a statistically significantly higher overall response rate for patients in the Abraxane arm compared with patients in the paclitaxel arm (33% vs 25%).
The most common adverse reactions associated with the use of Abraxane in combination with carboplatin for NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.
The following common adverse reactions were observed at a similar incidence in Abraxane plus carboplatin-treated and paclitaxel injection plus carboplatin-treated patients: alopecia 56%, nausea 27%, fatigue 25%, decreased appetite 17%, asthenia 16%, constipation 16%, diarrhea 15%, vomiting 12%, dyspnea 12%, and rash 10% (incidence rates are for the Abraxane plus carboplatin treatment group).
