Drug updated on 4/24/2024
| Dosage Form | Injection (intradermal, subcutaneous, subareolar, or peritumoral; 92.5 MBq (2.5 mCi) and 250 mcg of technetium Tc 99m tilmanocept) |
| Drug Class | Radioactive diagnostic agents |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated with or without scintigraphic imaging for lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in adult and pediatric patients age one month and older with solid tumors for which this procedure is a component of intraoperative management.
- Indicated with or without scintigraphic imaging for lymphatic 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.
Summary
- Technetium Tc 99m tilmanocept (Lymphoseek) is indicated for lymphatic mapping and sentinel lymph node biopsy in patients with solid tumors, including those with clinically node-negative squamous cell carcinoma of the oral cavity, breast cancer, or melanoma. It has a low molecular weight and specific affinity for mannose receptors present on lymphatic reticuloendothelial cells.
- The information was derived from one systematic review/meta-analysis that examined technetium Tc 99m tilmanocept's effectiveness and safety across different types of cancer.
- This drug demonstrates high preoperative and intraoperative detection rates for identifying at least one sentinel node across evaluated cancers: 1. Breast cancer: 0.94 preoperatively and 0.99 intraoperatively.
- Melanoma: 0.98 preoperatively and 1.00 intraoperatively.
- Head and neck cancer: 0.97 preoperatively and 0.99 intraoperatively.
- For melanoma specifically, the pooled sensitivity for detecting nodal metastasis was notably high at 0.97, indicating a strong diagnostic performance in identifying patients with nodal metastases.
- Compared to other radiotracers used, technetium Tc 99m tilmanocept appears highly effective but requires further multicenter trials to conclusively determine its superiority over others regarding effectiveness and safety.
- Although no distinct outcomes were specified within patient subgroups beyond broad categories such as breast cancer or head/neck cancers, it suggests the potential need for more research into understanding how this drug performs across various demographics or clinical subgroups within these categories.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Lymphoseek (technetium Tc 99m tilmanocept) Prescribing Information. | 2021 | Cardinal Health 414, LLC Dublin, OH |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| 99mTc-Tilmanocept performance for sentinel node mapping in breast cancer, melanoma, and head and neck cancer: a systematic review and meta-analysis from a European expert panel. | 2023 | European Journal of Nuclear Medicine and Molecular Imaging |