ESTROTEP (18F-fluoroestradiol), radiopharmaceutical for diagnostic use

DIAGNOSIS - New medicinal product
Opinions on drugs - Posted on Oct 18 2017

Reason for request

Inclusion

Insufficient clinical benefit in the absence of any role in the diagnostic strategy for oestrogen-receptor positive metastatic breast cancer

 

  • ESTROTEP is a radiopharmaceutical with marketing authorisation for positron emission tomography (PET) imaging for characterisation of metastatic lesions, known or suspected, as expressing oestrogen receptors in adult breast cancer, initially expressing the oestrogen receptor.
  • Given the lack of demonstrative data, especially in situations of difficult disease staging, the role of ESTROTEP in the diagnostic strategy has not been able to be defined in hormone-dependent metastatic breast cancer expressing oestrogen receptors. 

Clinical Benefit

Insufficient

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Therapeutic use

-

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