Bayer HealthCare has launched Xofigo (radium – 223 dichloride) solution for injection in the UK to treat adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases.
The launch follows a positive recommendation from the European Committee for Medicinal Products for Human Use and the marketing authorisation by the European Commission (EC) for Xofigo based on results from the Phase III ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial.
In the UK, Prostate cancer is the most common cancer in men and in 2010, about 41,000 men were newly diagnosed with the disease. The company said that on average,10-20% of prostate cancer patients develop castration-resistant prostate cancer (CRPC) in about five years of follow up and 84% of them have metastatic disease at the time of diagnosis.
ALSYMPCA trial principal investigator and The Royal Marsden NHS Foundation Trust Consultant Clinical Oncologist Christopher Parker said, “The majority of men who develop castration-resistant prostate cancer will develop bone metastases which can be painful and even life-threatening.”
The clinical safety and efficacy of Xofigo have been assessed in a double-blind, randomized, placebo-controlled trial of Xofigo with best standard of care vs. placebo with best standard of care in symptomatic CRPC patients with bone metastases.
Around 921 patients in more than 100 centres in 19 countries were enrolled in the trial, which included about six intravenous injections of Xofigo or placebo each separated by an interval of four weeks.
Primary efficacy endpoint in the trial was overall survival (OS), while secondary endpoints included time to symptomatic skeletal events (SSE), alkaline phosphatase (ALP) and prostate-specific antigen progression (PSA).
Bayer Business Unit head Specialty Medicine Jon Hemphill said the launch and availability of Xofigo in the UK should be welcomed news for physicians and patients, who have been looking for new treatment options.
“With today’s announcement, we reinforce our commitment to working closely with physicians, patients and other stakeholders to meet the needs of this community,” Hemphill said.
According to the company, the trial was stopped early after a pre-planned efficacy interim analysis, following a recommendation from an Independent Data Monitoring Committee, on the basis of achieving improvement in overall survival.
At the interim analysis, Xofigo has improved OS, while median OS was 14.0 months with Xofigo plus best standard of care vs. 11.2 months with placebo plus best standard of care.
Additionally, there was a delay in the time to first SSE for patients treated with Xofigo vs. placebo. An updated analysis, carried out after the trial was unblinded, demonstrated a further improvement in OS for patients treated with Xofigo vs. placebo, with a median OS of 14.9 months vs. 11.3 months.
Xofigo also showed improvement in both analyses compared to placebo in the secondary endpoints of total time to ALP progression, time to PSA progression.