Bayer addresses Xofigo shortage
The Society of Nuclear Medicine and Molecular Imaging (SNMMI) today released a statement from Bayer HealthCare dated Oct. 21 providing more information to healthcare professionals about the ongoing shortfall in Ra-223 dichloride (Xofigo) prescribed for castration-resistant prostate cancer with metastases to the bone.
Bayer officials noted in the letter they were in communication with the FDA to “increase the availability of the drug,” but they are still not yet sure when normal supply will resume.
According to the statement: “Recently produced Xofigo drug product batches did not pass routine quality checks. These batches have not been released for distribution and the production has been stopped. These routine quality checks are in place to identify a quality issue before distribution occurs. Bayer is taking the necessary actions to ensure high quality standards are restored and that production can be quickly resumed. A Xofigo drug shortage will lead to interruption of patients’ treatment, and inability to initiate treatment for new patients until product is available.”
The letter noted that currently circulating supply is not affected. It also provided details of a recent study (phase III ALSYMPCA) to demonstrate how to approach dose delays. The study guidelines propose that treatment periods happen in four-week intervals (plus seven days or minus three days). The same four-week interval should be maintained between all treatments and administration should not be delayed any longer than four weeks. If delays go beyond four weeks, the study recommends stopping treatment.
Bayer’s notice included an ad hoc analysis of the study that showed similar exposure and overall safety for approximately 30 percent (178) of the patients, all of whom experienced longer delays.
From the letter: “However, caution should be used in interpreting these data as this was an unplanned, sub-group analysis. For those patients currently on Xofigo that have experienced a cancellation or a dosing delay, their treating physician should take into consideration the duration of the delay as well as alternative treatment options when determining the best care for their patient.”
No further information is available at this time regarding the steps being taken to restore availability of the drug.
“Bayer is in regular communications with physicians and investigators who treat patients with Xofigo to provide information on product availability.”