BWXT medical submits drug master file for Actinium-225 API to U.S. FDA

The drug is an alpha-emitting isotope used in targeted alpha therapies, targeting vectors to kill cancer cells while minimising the impact to healthy tissues

BWXT Medical has recently submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active Pharmaceutical Ingredient.

Ac-225 is an alpha-emitting isotope used in targeted alpha therapies (TATs) that combine the isotope with specific tumour-seeking targeting vectors to kill cancer cells while minimising the impact to healthy tissues.

The statement informs, “There is growing demand for the isotope, but there are a limited number of suppliers that are currently able to produce meaningful quantities of high purity actinium. One such technology is high-energy proton spallation of thorium targets that are produced and irradiated in collaboration with TRIUMF. Irradiation at high energy favours the production of Ra-225, which can be isolated and loaded onto a generator. Elution of this generator yields high purity Ac-225, which does not contain the long-lived impurity Ac-227.”