LYMPHOSEEK (tilmanocept), radiopharmaceutical for diagnostic use

DIAGNOSTIC - New medicinal product
Opinions on drugs - Posted on Feb 14 2019

Reason for request

Inclusion

High clinical benefit in the detection of sentinel nodes, but no demonstrated clinical advantage over NANOCIS, NANOCOLL or ROTOP-Nano-HSA.

 

  • LYMPHOSEEK is authorized for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity..

  • It plays the same role in the therapeutic strategy than NANOCOLL, NANOCIS and ROTOP-Nano-HSA depending on indications, when SN detection is necessary.

  • In squamous cell carcinoma of the oral cavity, the rate of false negatives with LYMPHOSEEK was of 2.56%, below the threshold of 14%predetermined from the literature.

  • In breast cancer and melanoma, the diagnostic performance established versus patent blue showed a node-level concordance rate of more than 90%, along with an exploratory false negative rate of between 0 and 7.3%, depending on the study.

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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