Pemetrexed, a folate analogue metabolic inhibitor, has been approved as the first maintenance treatment for locally advanced or metastatic nonsquamous non–small cell lung cancer, the U.S. Food and Drug Administration announced in a statement on July 6.

“This drug represents a new approach in the treatment of advanced non–small cell lung cancer,” Dr. Richard Pazdur, director of the FDA’s office of oncology drug products, said in the statement. “Typically, patients whose tumors respond to chemotherapy do not receive further treatment after four to six chemotherapy cycles,” he added.

Dr. Pazdur referred to a study that showed an advantage in overall survival in certain patients who received maintenance therapy with pemetrexed.

Maintenance therapy with pemetrexed was compared with placebo in a multicenter study of 663 patients with stage IIIb/IV non–small cell lung cancer, whose disease had not progressed after four cycles of platinum-based chemotherapy.

Among those with nonsquamous small cell lung cancer treated with pemetrexed (481 patients), overall survival was a median of 15.5 months, vs. 10.3 months among those who received a placebo. In this group, progression-free survival was a median of 4.4 months among those on pemetrexed, compared with 1.8 months among those on placebo, according to the prescribing information.

No benefit was seen among patients with predominantly squamous cell cancer. The drug is not approved for patients with squamous cell non–small cell lung cancer.

Dr. Chandra P. Belani of Penn State Cancer Institute in Hershey, Pennsylvania, reported the pemetrexed findings at this year’s annual meeting of the American Society of Clinical Oncology.

Pemetrexed, marketed as Alimta in the United States by Eli Lilly & Co., was approved in September 2008 for treating locally advanced or metastatic nonsquamous non–small cell lung cancer in combination with cisplatin, or after previous chemotherapy. It is administered intravenously. Pemetrexed was initially approved in 2004 for treating patients with mesothelioma.

To view a video interview of Dr. Belani, go to www.youtube.com/watch?v=9S_-jhW_FoE.

Copyright (c) 2009 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

美国食品药品管理局(FDA)在7月6日的一份声明中宣布：叶酸拮抗剂培美曲塞(pemetrexed)已获批准，成为局部晚期或转移性非鳞状上皮细胞非小细胞肺癌首个维持治疗用药。

 

“该药物为晚期非小细胞肺癌提供了一种新的治疗模式。” 美国FDA肿瘤学药品办公室主任Richard Pazdur博士在声明中说道，“患者在接受4~6个周期化疗后无效，则通常不再做进一步的治疗。”他补充说。

 

Pazdur博士提到的一项研究显示，接受培美曲塞维持治疗的患者在总体生存率上具有优势。

 

一项多中心研究对培美曲塞维持治疗做了安慰剂对照研究，共纳入663例经4个周期以铂类药物为主的化疗后无疾病进展的IIIb/IV期非小细胞肺癌患者。

 

其中接受培美曲塞的481例非鳞状上皮细胞非小细胞肺癌患者的总存活时间中位数为15.5个月，安慰剂组为10.3个月。根据处方信息，培美曲塞组无进展存活时间中位数为4.4个月，安慰剂组为1.8个月。

 

以鳞状细胞为主非小细胞肺癌患者未能从培美曲塞维持治疗中获益，因此该药未被批准用于此类患者。

 

宾夕法尼亚州Hershey州立癌症研究所的Chandra P. Belani博士在今年的美国临床肿瘤学会年会上报告了上述研究结果。

 

培美曲塞是美国礼来公司推出的抗癌新药，销售商品名为力比泰(Alimta)。该药用于静脉注射，最初在2004年获美国FDA批准用于治疗间皮瘤，2008年9月获批用于初次化疗后或联合顺铂治疗局部晚期或转移性非鳞状上皮细胞非小细胞肺癌。

 

观看Belani博士的采访视频，请访问www.youtube.com/watch?v=9S_-jhW_FoE。