The US Food and Drug Administration has invited Amgen to attend the Oncologic Drugs Advisory Committee (ODAC) meeting on February 8, 2012. There, it would also be decided whether its XGEVA should be allowed for the treatment of men suffering from castration-resistant prostate cancer (CRPC).

The medicine is also available with the name “Denosumab and Prolia” and is given to elderly women suffering from osteoporosis. It is also given to prevent bone fractures among cancer patients.

The company now wants that their medicine should also be allowed to men suffering from prostate cancer. In order to decide, the committee would review clinical studies results taken out to know medicine’s efficacy. In the trial, 147 people were enrolled and randomly they were asked either to take dummy capsule or Xgeva.

The stage-three clinical trials have showed results in favor of the company. But, the committee wants to assess the findings first. In the meeting, the drug company is also expected to present reasons that why its drug should be approved for CRPC usage.

Amgen would also be announcing that if its drug is allowed for the said treatment, it would also supply the drug to developing countries as CRPC problem is most found there and they do not even have effective medicine for it.

The countries where Xgeva is approved are Canada, Switzerland, Australia and Russia. But, it is not approved for CRPC, as it is instead being used for the prevention of SREs in patients with bone metastases from solid tumors.

In clinical trials, such instances have happened where people have complaint of nausea, fatigue and dyspnea and hypocalcemia. Therefore, it would be very important for the committee to see pros and cons and then decide that either its use should be extended for CRPC patients or not.