FDA Approves Cyclotron-Produced Ga-68 DOTATOC for Neuroendocrine Tumors

October 20, 2020

On October 14, the University of Iowa received approval for a new process for producing gallium-68 (Ga-68) DOTATOC, which localizes neuroendocrine tumors (NETs) in adult and pediatric patients. The new process utilizes cyclotron-produced Ga-68, which will allow for higher-volume production.

The University of Iowa received approval last year to use a Ge-68/Ga-68 generator in combination with a cassette-based synthesis module to manufacture the Ga-68 DOTATOC. They then filed a supplement to their new drug application to produce the radiopharmaceutical using cyclotron-produced Ga-68 rather than a Ge-68/Ga-68 generator.

The newly approved process uses a liquid target filled with a zinc-68 solution to produce Ga-68 in the cyclotron. The target solution is transferred to a cassette-based synthesis module that purifies the gallium-68 and performs the chemistry process to manufacture Ga-68 DOTATOC.

The advantage of cyclotron-produced Ga-68 DOTATOC is consistent production of 40-50 mCi of Ga-68 DOTATOC rather than the 10-25 mCi typically produced by a Ge-68/Ga-68 generator. The NDA is for a multi-dose vial, which will allow for multiple patients to be injected per vial. In addition, the new process provides a viable alternative to Ge-68/Ga-68 generators for facilities with cyclotrons.

The University of Iowa has waived exclusivity for the Ga-68 DOTATOC NDA and encourages everyone to file ANDAs based on this NDA. For details on the Chemistry, Manufacturing, and Controls (CMC) section of the NDA, contact David Dick at the University of Iowa.