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. 2023 Apr 26;96(1149):20221153. doi: 10.1259/bjr.20221153

Table 2.

Dates of FDA and EMA approval of PET radiopharmaceuticals used in breast cancer with the respective clinical indication and type of recommendation/document

PET radio pharmaceutical FDA approval EMA approval Clinical indications Type of recommendation
(date of last update)
[18F]NaF 1972 2015
EMA/212874/2015
Bone metastases identification and treatment response assessment
  • EANM/SNMMI guideline (2015) 38

  • NCCN guidelines (2023) 10

2-[18F]FDG 2000
(for oncology)
2018
EMA/496103/2018
Whole-body
  • Systemic staging of patients with clinical Stage IIB – IV

  • Lesion detection when there is suspicion of recurrence

  • Assessing response to treatment


Breast-dedicated imaging
  • MRI contraindication

Whole-body
  • ESMO guidelines (2019) 6

  • ESTRO guidelines (2020) 39

  • ESMO guidelines (2021) 40

  • NCCN guidelines (2023) 10

  • EANM/SNMMI guideline being revised*

    Breast-dedicated imaging

  • EANM/SNMMI guideline being planned*

[18F]FES
(CeriannaTM )
2020 Not approved
  • Detection of ER-positive lesions in patients with recurrent or metastatic BC

  • Patients selection for hormonal therapies

  • NCCN guidelines (2023) 10

  • EANM/SNMMI guideline being revised*

BC, breast cancer; PET, positron emission tomography.

*Some authors are participating in these guidelines.