A production problem has resulted in a shortage of Bayer HealthCare's Xofigo (radium-223 dichloride) therapeutic radiopharmaceutical.
The drug is used to treat patients who have castration-resistant prostate cancer (CRPC) with symptomatic bone metastases and no known visceral metastatic disease.
In its October 17 announcement, Bayer stated that Xofigo "did not meet the high quality standards, due to small fibrous particles found in some of the vials. Therefore, this drug product was not distributed."
There are no quality problems with previously distributed Xofigo, the company noted.
Bayer did not give an estimate of when Xofigo distribution would resume, but the company plans to stay in touch with physicians and regulators to provide periodic updates on the availability of the product.