血管生成抑制剂获准用于进展期胃癌

美国食品药品管理局（FDA） 4月21日宣布，人血管内皮生长因子受体2拮抗剂ramucirumab已获准用于进展期胃癌或胃食管连接部腺癌患者治疗。

根据处方信息，该药物可作为之前接受以氟嘧啶或铂类为基础的化疗患者的单药治疗，每2周静注给药1次。

FDA药品评价与研究中心血液与肿瘤药品办公室主任Richard Pazdur博士在声明中指出，已证实ramucirumab可延长患者生命，减缓肿瘤生长，是一种新的治疗选择。

该批准令是基于一项纳入355例不能切除或转移的胃癌或胃食管结合部癌症患者的研究结果。Ramucirumab治疗组患者中位总生存期为5.2个月，而安慰剂组为3.8个月，风险比（HR）为0.78（P =0.047）。Ramucirumab治疗组无进展生存期也优于安慰剂组，分别为2.1个月和1.3个月，具有统计学显著意义（HR，0.48）。在另外一项比较ramucirumab联合紫杉醇和紫杉醇单药治疗的研究中，联合用药组患者总生存期也具优势。

腹泻和高血压是临床试验中常见的与该药物相关的不良事件。处方信息中包含了一项有关出血（包括严重以及有时是致命性出血事件）风险增加的黑框警告。

FDA声明指出，据美国国家癌症研究所估计，美国今年新增胃癌患者22,220例，胃癌死亡病例10,990例。Pazdur博士在声明称：“尽管过去40年美国胃癌发病率已有所降低，但患者仍需要新的药物选择，尤其是对于其他药物治疗不再产生应答的患者。”

鉴于胃癌属于罕见病，ramucirumab被授予孤儿药（罕用药）地位，并获优先审评。该药物将由礼来制药公司以商品名Cyramza上市销售。

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By: ELIZABETH MECHCATIE, Oncology Practice Digital Network

Ramucirumab, a human vascular endothelial growth factor receptor 2 antagonist, has been approved as a treatment for people with advanced gastric cancer or gastroesophageal junction adenocarcinoma, the Food and Drug Administration announced on April 21.

It is intended for use as a single-agent treatment after prior fluoropyrimidine- or platinum-containing chemotherapy, and is administered intravenously every 2 weeks, according to the prescribing information.

Ramucirumab "is a new treatment option that has demonstrated an ability to extend patients’ lives and slow tumor growth," Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s statement announcing approval.

Approval was based on a study of 355 people with unresectable or metastatic stomach or gastroesophageal junction cancer. The median overall survival among those treated with ramucirumab was 5.2 months, compared with 3.8 months among those on placebo, according to the FDA statement. The hazard ratio was 0.78 (P = .047). Progression-free survival also favored those on ramucirumab: 2.1 vs 1.3 months among those on placebo, which was statistically significant (HR, 0.48). In a second study that compared treatment with ramucirumab plus paclitaxel, to paclitaxel alone, overall survival also favored those in the group treated with the combination.

Diarrhea and hypertension were common adverse events associated with treatment in clinical trials. The prescribing information includes a boxed warning about the increased risk of hemorrhage, including severe and sometimes fatal hemorrhagic events.

The FDA statement cited National Cancer Institute estimates that 22,220 Americans will be diagnosed with stomach cancer and 10,990 will die of stomach cancer this year. "Although the rates of stomach cancer in the United States have decreased over the past 40 years, patients require new treatment options, particularly when they no longer respond to other therapies," Dr. Pazdur said in the statement.

Ramucirumab, which was granted orphan drug status because stomach cancer is a rare disease, was granted a priority review; it will be marketed as Cyramza by Eli Lilly.