European Medicines Agency Recommends Granting a Marketing Authorisation for Radium-223 Chloride

Approved indication concerns patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases

On 19 September 2013, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product radium-223 chloride (Xofigo), 1000 kBq/mL, solution for injection, intended for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.

The applicant for this medicinal product is Bayer Pharma AG. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.

The active substance of Xofigo is radium-223 chloride, a therapeutic pharmaceutical (ATC Code: V10XX03) that mimics calcium and preferentially targets bone, thereby relaying high linear energy from alpha radiation emitters generated during its radioactive decay to adjacent cells which is claimed to affect bone turnover (inhibition of osteoclast differentiation and osteoblast activity) and to be cytotoxic to cancer cells of bone metastases.

The benefits with radium-223 chloride are its ability to improve survival and to delay skeletal-related events (such as pathological fractures, spinal cord compression and use of radiation to relieve symptoms or surgery to treat complications).

The most common side effects are diarrhoea, nausea, vomiting and thrombocytopenia.

A pharmacovigilance plan for radium-223 chloride will be implemented as part of the marketing authorisation.

The approved indication is: "Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases”.

It is proposed that radium-223 chloride should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings and after evaluation of the patient by a qualified physician.