BWXT Medical Submits Drug Master File on Actinium-225 for Cancer Treatment

The U.S. Food and Drug Administration has started reviewing BWXT Medical’s No Carrier Added Actinium-225 active pharmaceutical ingredient.

On Friday, the health science company announced that it had filed a drug master file with the FDA as it seeks to use Ac-225 to kill cancer cells while minimizing its impact on healthy tissues.

A DMF submission provides the FDA with confidential, detailed information concerning a company’s processes, facilities and articles used to manufacture, process, package and store drug products meant for human consumption, BWXT Medical said.

Jonathan Cirtain, president and CEO at BWXT Medical and a 4×24 member, said that the DMF submission reflects the company’s commitment to quality and regulatory excellence, ensuring that BWXT’s practices follow the highest standards of safety and efficacy.

BWXT Medical’s DMF submission follows the achievement of another company focused on Ac-225 production. In early June, cyclotron technology innovator and radiopharmaceutical manufacturer IONETIX announced that it had completed production of Ac-225 in its Michigan facility, a development that ensures a stable, secure and robust commercial-stage supply of Ac-225.