![]() ![]() The short range of alpha particle radiation allows to minimize cytotoxic damage in non-targeted cells, enabling specific cancer cell targeting with reduced toxicity to normal cells. Alpha particles have a short path length in tissue (50-100 μm) compared with beta particles (1000-10,000 μm). ![]() The total amount of emitted energy per the 223Ra decay series is 28.2 MeV. Radium-223 decays in six steps via a chain of alpha and beta emissions into a stable isotope of lead, 207Pb. Radium-223 is an alpha emitter with a physical half-life of 11.4 days and a whole body effective half-lives were highly dependent upon fecal compartment transfer, ranging from 2.5-11.4 d. Radium-223 dichloride is an FDA-approved alpha-particle emitting therapeutic radiopharmaceutical agent indicated for the treatment of patients with castration-resistant prostate cancer (mCRPC), symptomatic bone metastases and no visceral metastatic disease. By analogy, this trending issue is involving the novel radiopharmaceutical Radium-223 and its administration. Nevertheless, even if quite rare, the possibility of adverse reaction to an administered radiopharmaceutical does exist. The frequency of reported adverse effects is generally considered to be 0.1% compared to that relative to other drugs, so the radiopharmaceuticals are regarded as safe medicines. ![]() The final stage of the review procedure is the adoption by the EC of a legally binding decision applicable in all EU Member States.The growth and expansion of nuclear medicine procedures and the corresponding use of radiopharmaceuticals lead to an increase in the frequency of adverse reactions. Once the PRAC review is concluded, any further recommendations will be forwarded to the Committee for Medicinal Products for Human Use (CHMP), responsible for evaluating medicines for human use, which will adopt a final opinion. This will be forwarded to the European Commission (EC), which will issue a provisional legally binding decision applicable in all EU Members States. The review is being carried out by the, the EMA’s Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.ĭuring the review, the PRAC made provisional recommendations to protect public health. The review of Xofigo has been initiated at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004. Xofigo was authorised in the European Union in November 2013. The ongoing study of Xofigo in combination with Zytiga and prednisone/prednisolone included patients with castration-resistant prostate cancer that has spread mainly to the bones, who have no symptoms or only mild symptoms and who have not been treated with chemotherapy. ![]() EMA will communicate further at the conclusion of the review. These are temporary measures until the ongoing in-depth review of the benefits and risks of Xofigo is complete. Healthcare professionals are also warned that the safety and efficacy of Xofigo in combination with a class of second generation androgen receptor antagonists, such as Xtandi ( enzalutamide), have not been established. Healthcare professionals in the EU must not use a combination of Xofigo with the anti-androgen Zytiga and prednisone/prednisolone, and should stop this combination in men currently treated with it and review the treatment for these patients.īoth medicines can continue to be used separately, in line with the recommendations in their product information. Patients have completed the Xofigo part of the study, and the combination is no longer being used all the patients involved are being monitored closely. The ongoing clinical study includes metastatic prostate cancer patients who have not previously received chemotherapy and who have no symptoms or only mild symptoms, such as pain. Xofigo is currently authorised for use in men whose prostate cancer has spread to the bones and is causing symptoms. In view of the seriousness of the events reported, the PRAC has taken action by introducing a contraindication as a temporary measure to protect patients’ safety while an in-depth review of the benefits and risks of Xofigo is ongoing. In this study 34.7% of patients treated with Xofigo, Zytiga and prednisone/prednisolone have died so far, compared with 28.2% of patients given placebo, Zytiga and prednisone/prednisolone.įractures have also occurred more frequently with the Xofigo combination than the placebo combination (26% versus 8.1%). On 9 March 2018, the European Medicines Agency (EMA) has recommended contraindicating the use of the prostate cancer medicine Xofigo (radium-223 dichloride) with Zytiga ( abiraterone acetate) and prednisone/prednisolone, due to an increased risk of death and fractures with this combination.ĮMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has reviewed the preliminary data from an ongoing clinical study in metastatic prostate cancer patients. ![]()
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