2014年6月13日，美国FDA批准Lymphoseek(锝99m tilmanocept)注射剂一种新用途，这款药物是一种放射性诊断影像剂，帮助医生确定鳞状细胞癌已扩散至人体头部及颈部的程度。
2013年，Lymphoseek被批准用来帮助鉴别乳腺癌及黑色素瘤患者体内离原发性肿瘤最近的淋巴结。
由于今天的批准，Lymphoseek现在可用来指导头颈癌患者最接近于癌症原发性肿瘤的淋巴结的检查，也叫前哨淋巴结活组织检查。这种新的适应症可以为癌症前哨淋巴结活组织检查阴性患者选择更加有限的淋巴结手术。
“对一些患有头颈癌的患者来说，排出原发性肿瘤的淋巴结的切除及病理学检查是一种重要的诊断评价，”FDA药品评价与研究中心医学影像产品的部门主任、医学博士、哲学博士Marzella说。“使用Lymphoseek时，医生将这款药物注射入肿瘤部位，然后使用手持放射性检测器，可发现已吸收Lymphoseek放射性的前哨淋巴结。”
对于这种新的适应症，Lymphoseek的安全性及有效性在一项85名患有嘴唇、口腔和皮肤鳞状细胞癌患者参与的试验中得到验证。所有患者被注射入Lymphoseek。外科医学随后切除病理检查疑似淋巴结（那些被Lymphoseek证实及那些基于肿瘤位置和手术实践的淋巴结）。结果显示，Lymphoseek指导的前哨淋巴结活组织检查可以确定癌症是否已通过淋巴系统发生扩散。
临床试验中最常见的副作用是疼痛或注射部位刺激。Lymphoseek由位于俄亥俄州都柏林的Navidea生物制药上市销售。
Lymphoseek® (technetium Tc 99m tilmanocept) injection is a first-in-class mannose receptor (CD206) binding radiopharmaceutical agent developed for use in external lymph node imaging (lymphoscintigraphy), intra-operative lymphatic mapping (ILM) and sentinel lymph node biopsy.
Lymphoseek Indication and Important Safety Information
Lymphoseek is a radioactive diagnostic agent indicated with or without scintigraphic imaging for:
Lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management.
Guiding sentinel lymph node biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
LYMPHOSEEK Rx
Generic Name and Formulations:
Technetium Tc 99m tilmanocept 250mcg; pwd for SC, intradermal, or peritumoral inj after reconstitution. After radiolabeling (with technetium Tc 99m + dilution); contains approx. 92.5 MBq (2.5 mCi) and 250mcg of technetium Tc 99m tilmanocept in 0.5–5mL total volume.
Company:
Navidea Biopharmaceuticals
Indications for LYMPHOSEEK:
Using a hand-held gamma counter: for lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma; for guiding sentinel lymph node biopsy in patients with clinically node negative squamous cell carcinoma (SCC) of the oral cavity.
Adult:
See full labeling. Determine the planned injection technique and the number of injections per patient prior to preparing dose. May be administered as a single injection or multiple injections. Give 18.5MBq (0.5mCi) as a radioactivity dose and 50mcg as a mass dose, at least 15mins before initiating intraoperative lymphatic mapping; do not delay mapping >15hrs after injection. Total injection volume per patient: 0.1mL in single syringe; 0.5mL in single or in multiple syringes (0.1–0.25mL each); or 1mL in multiple syringes (0.2–0.5mL each). Route of administration: Breast cancer: intradermal, SC, subareolar, peritumoral; Melanoma: intradermal or SC.
Children:
<18yrs: not established.
Warnings/Precautions:
Previous hypersensitivity to dextran or other modified forms. Have resuscitation equipment available. Risk of radiation exposure. Should only be used by trained and experienced physicians in the safe use and handling of radioactive materials to minimize radiation exposure. In females of reproductive potential: administer within 10 days following the onset of menses or perform a pregnancy test within 48hrs prior to the administration. Pregnancy (Cat. C). Nursing mothers (discard milk for at least 4hrs after administration).
Interactions:
Co-injection (mixture) with local anesthetics: not recommended.
Pharmacological Class:
Radioactive diagnostic agent.
Adverse Reactions:
Injection site irritation and/or pain.
How Supplied:
Kit—1 (5 vials + 5 diluents; supplies)
|
