University of California San Francisco: Floretyrosine F

Evidence provided as confirmatory evidence of effectiveness was not sufficiently strong to complement study 18F-TLX101-CDx-203. Four studies were examined as confirmatory evidence, including one re-read of images obtained from expanded access use of floretyrosine F 18, GBM-RET-01, and three published retrospective studies.

GBM-RET-01 used a higher administered activity than intended for labeling, had potential for unblinding of the reference standard evaluators, and had more than 10% of patients with missing reference standard results.

The remaining studies shared design issues including use of different image evaluation methods than intended for labeling and lack of per reader results.

To address these issues, a second adequate and well-controlled efficacy study, which could be conducted in the same patient population or a closely related condition, or other robust confirmatory evidence of efficacy is necessary.

Optimization of the administered dose of floretyrosine F 18 could also be considered.

The safety update should include data from all nonclinical and clinical studies/trials of floretyrosine F 18 under consideration regardless of indication, dosage form, or dose level.