FDA Gives Fast-track Status to Algeta's Prostate Cancer Treatment
Algeta's radium-223 chloride has been granted fast-track designation by the FDA for the treatment of castration-resistant prostate cancer in patients with bone metastases.
The US FDA has granted fast-track status for Algeta's radium-223 chloride as a treatment for castration-resistant prostate cancer in patients suffering from bone metastases.
A Phase III trial, conducted by Algeta and Bayer Pharma, investigated radium-233 chloride for treating symptomatic bone metastases in castration-resistant prostate cancer patients. The treatment met the primary endpoint by improving overall survival.
The safety and tolerability of radium-223 chloride were consistent with previous Phase I and Phase II trial outcomes and did not show any new or unexpected changes in its safety profile.
Under the terms of an agreement signed in 2009, Bayer will develop, apply for global health authority approval
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