US Food and Drug Administration approval: Panitumumab for epidermal growth factor receptor-expressing metestetic colorectal carcinoma with progression following fluropyrimidine-, oxelipletin-, and irinotecen-containing chemotherapy regimens
US Food and Drug Administration approval: Panitumumab for epidermal growth factor receptor-expressing metestetic colorectal carcinoma with progression following fluropyrimidine-, oxelipletin-, and irinotecen-containing chemotherapy regimens
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DOI：
10.1158/1078-0432.ccr-07-1354
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发表时间：
2008-03-01
影响因子：
11.5
通讯作者：
Pazdur, Richard
中科院分区：
文献类型：
--
作者：
Giusti, Ruthann M.;Shastri, Kaushikkumar;Pazdur, Richard
目的：描述美国食品和药物管理局对帕尼珠单抗（Vectibix）用于表皮生长因子受体表达转移性结直肠癌患者三线治疗的审查和上市批准考虑。实验设计：美国食品和药物管理局回顾了一项单一、开放标签、多中心的试验，其中463例表皮生长因子受体表达的转移性结直肠癌患者在氟嘧啶、奥沙利铂和伊立替康治疗方案中或之后进展，随机（1:1）接受最佳支持治疗（BSc），有或没有帕尼珠单抗（每隔一周6 mg/kg），直到疾病进展或无法忍受的毒性。进展和反应由一个独立的审查委员会对治疗分配进行确认。在进展阶段，bsc单独组的患者有资格接受帕尼单抗治疗。结果：尽管两个治疗组的中位无进展生存期（PFS）相似（相似于8周），但接受帕尼单抗的患者的平均PFS比单独接受BSC的患者长50%（分别为96天和60天），接受帕尼单抗的患者的客观缓解率为8%。然而，两个研究组的总生存率没有差异。结论：基于PFS的改善和独立证实的8%的缓解率，Panitumumab获得了加速批准，与其他活性药物在这种晚期疾病中观察到的相似。临床效益的确认将需要全面批准。
Purpose: To describe the Food and Drug Administration review and marketing approval considerations for panitumumab (Vectibix) for the third-line treatment of patients with epidermal growth factor receptor-expressing metastatic colorectal carcinoma.Experimental Design: Food and Drug Administration reviewed a single, open-label, multicenter trial in which 463 patients with epidermal growth factor receptor-expressing metastatic colorectal cancer who had progressed on or following treatment with a regimen containing a fluoropyrimidine, oxaliplatin, and irinotecan were randomized (1:1) to receive best supportive care (BSc) with or without panitumumab (6 mg/kg every other week) administered until disease progression or intolerable toxicity. Progression and response were confirmed by an independent review committee masked to treatment assignment. At progression, patients in the BSc-alone arm were eligible to receive panitumumab.Results: Although median progression-free survival (PFS) was similar in both treatment arms (similar to 8 weeks), the mean PFS was similar to 50% longer among patients receiving panitumumab than among those receiving BSC alone (96 versus 60 days, respectively) and the objective response rate in patients receiving panitumumab was 8%. However, no difference in overall survival was shown between the two study arms.Conclusions: Panitumumab received accelerated approval based on improvement in PFS and an independently confirmed response rate of 8%, similar to that observed with other active agents at this advanced stage of disease. Confirmation of clinical benefit will be required for full approval.