Regulatory Decision Summary for Sodium Pertechnetate ( 99m Tc) Injection

Authorization was based on results of a small bridging study and literature data. The clinical study was conducted to demonstrate that BCCA's cyclotron-produced Sodium Pertechnetate (^99mTc) Injection has a comparable diagnostic performance to generator produced pertechnetate (^99mTc). Sixty patients underwent imaging procedures with both drug products. Scans were read by two readers blinded to all other clinical information. The primary endpoint was the blinded comparison of the images generated with the cyclotron-produced ^99mTc pertechnetate (CPP) and the standard of care radiopharmaceutical, in the differential diagnosis of hyperthyroidism. Results of the study showed that there are no clinically detectable differences in the diagnostic interpretation or image quality of the images produced from the cyclotron-produced and generator-produced sodium pertechnetate (^99mTc).

A total of 9 adverse events (AEs) were reported by 6 patients, and none of the AEs were considered to be related to the radiopharmaceuticals. Based on the literature, adverse drug reactions (ADRs) following sodium pertechnetate (^99mTc) administration are very rare, usually mild to moderate and transient; no severe adverse reaction has been reported to date.

Radiation dosimetry calculations indicate that technetium radioactive impurities will lead to a 2-3% increase radiation dose to patients, which is well below the clinically significant limit.