FDA批准淋巴结定位显影剂

美国食品药品管理局(FDA)宣布，放射性诊断显影剂Lymphoseek(99m锝替马诺噻)注射剂已获准用于正在接受肿瘤引流淋巴结手术切除治疗的乳腺癌或黑色素瘤患者的淋巴结定位。

Lymphoseek是30多年来首个获准用于淋巴结定位的新药。FDA已批准用于淋巴结定位的其他药物包括硫胶体和异硫蓝。

FDA药物评价和研究中心药物评价四室副主任Shaw Chen博士称：“应用Lymphoseek时，医生将该药物注射至肿瘤部位，然后使用手持放射性检测器，可发现已吸收Lymphoseek放射性的淋巴结。”

Lymphoseek由Navidea生物制药公司投入市场。该公司网站指出，能够快速定位和活检前哨淋巴结，可使医生能够根据每位患者的具体疾病负担实施个体化手术治疗。

在2项临床试验中，332例黑色素瘤或乳腺癌患者注射Lymphoseek和蓝染色素后，外科医生切除疑似淋巴结行病理检查，并对确认的淋巴结中蓝染色素和Lymphoseek含量进行检测。尽管有一定数量的淋巴结只有通过Lymphoseek才能定位，但大多数淋巴结可通过Lymphoseek和蓝染色素联合定位。

临床试验中最常见的副作用是注射部位疼痛和刺激。

据生产商称，一项纳入头颈部癌症患者的临床试验即将完成入组，期望作为未来新药申请修正的依据。预计2012年底向欧盟提交最初上市许可申请。

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By: MARY JO DALES, Oncology Practice

A radioactive diagnostic imaging agent called Lymphoseek (technetium Tc 99m tilmanocept) Injection has been approved for locating lymph nodes in patients who have breast cancer or melanoma and are undergoing surgery to remove tumor-draining lymph nodes, the Food and Drug Administration announced.

Lymphoseek is the first new drug for lymph-node mapping to be approved in more than 30 years. Other FDA-approved drugs used for lymph-node mapping include sulfur colloid and isosulfan blue.

"To use Lymphoseek, doctors inject the drug into the tumor area and later, using a handheld radiation detector, find lymph nodes that have taken up Lymphoseek’s radioactivity," said Dr. Shaw Chen, deputy director of the Office of Drug Evaluation IV in the FDA’s Center for Drug Evaluation and Research.

Lymphoseek is marketed by Navidea Biopharmaceuticals. The manufacturer’s website notes that the ability to rapidly locate and biopsy sentinel nodes enables surgical management to be tailored specifically to each patient’s burden of disease.

In two clinical trials, 332 patients with melanoma or breast cancer were injected with Lymphoseek and blue dye. Surgeons subsequently removed suspected lymph nodes for pathologic examination. Confirmed lymph nodes were examined for their content of blue dye and Lymphoseek. The combination of Lymphoseek and blue dye localized most lymph nodes, although a notable number of nodes were localized only by Lymphoseek.

The most common side effects identified in clinical trials were pain and irritation at the injection site.

According to the manufacturer, a clinical trial involving patients with head and neck cancer is completing enrollment and is expected to be the subject of a future New Drug Application amendment. An initial Marketing Authorization Application filing in the European Union is anticipated by the end of 2012.