Objective:

To report the FDA approval of florquinitau F18 injection (TAUKLARIFY) for tau PET imaging in adults with cognitive impairment undergoing evaluation for Alzheimer’s disease.

Approach:

• Study Design: Two blinded read studies evaluated TAUKLARIFY PET images from over 500 participants across three clinical trials, including those with mild cognitive impairment, mild Alzheimer’s disease dementia, and cognitively unimpaired participants.
• Image Assessment: Independent readers assessed scans while blinded to clinical information and amyloid beta PET results, classifying them as positive or negative for tau neurofibrillary tangle pathology.

Key Findings:

• Study 1 showed positive percent agreement of 80% to 88% and negative percent agreement of 98% to 99% across 279 participants.
• Study 2 showed positive percent agreement of 68% to 82% and negative percent agreement of 93% to 99% across 338 participants.
• High inter-reader agreement was observed in both studies.
• Safety assessment in 1,734 participants reported low incidence of headache (0.7%), nausea (0.2%), and other minor reactions (0.1%).

Interpretation:

TAUKLARIFY may perform less effectively in identifying tau pathology in earlier stages of the disease, and negative results do not exclude the presence of tau neurofibrillary tangle pathology.

Limitations:

• TAUKLARIFY contributes to cumulative radiation exposure, which is linked to a higher cancer risk.
• Safety and effectiveness for evaluating non-Alzheimer’s disease tauopathies have not been established.

Conclusion:

Positive and negative scan results should be interpreted within the context of the full clinical evaluation.

Sources:

• Lantheus Holdings