Xofigo is the first alpha particle-emitting radioactive therapeutic agent that has showed improvement in overall survival (OS) and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal phase III Alsympca trial.
Algeta president and CEO Andrew Kay said that the company is pleased to make the alpha particle-emitting pharmaceutical available to US patients with castration-resistant prostate cancer and symptomatic bone metastases.
"We will now finalize our launch preparations for Xofigo in the US, with the intention of launching it, with Bayer, as soon as possible. This approval is a major milestone for Algeta and puts us firmly on the path to deliver on our vision to be a world-class oncology company bringing novel targeted medicines to cancer patients through our leadership in alpha particle-emitting pharmaceuticals," Kay added.