An update on the shortage of radium-223 (Xofigo)

On October 21, here in the USA, Bayer HealthCare Pharmaceuticals issued a Dear Healthcare Professional letter to medical professionals indicating that the company still does not know when it is likely to be able to start to re-supply this radiopharmaceutical agent for the treatment of late-stage prostate cancer. The company simply says that it is “currently coordinating” with the U.S.Food and Drug Administration (FDA) to address the current situation.

The letter does provide some information related to delays in administration of radium-223 in the Phase III ALSYMPCA trial and the fact that delays in administration did not appear to affect drug efficacy or safety during that trial.

3 Responses

  1. Still seems very odd that Bayer can give so little information.

  2. Robin:

    Frustrating though this does seem to be, my suspicion is that Bayer feels that there is very little the company can say publicly until they have a clear signal from the global regulatory community (i.e., the European and US regulatory agencies in particular) about what must be done to resolve whatever the problem is or was.

  3. They have been hush about it. But they are also dealing with a radioactive agent and might be limited on what they can say about the production process. Thanks for the update letter, Mike. Printed and ready to share.

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