FDA OKs novel injection for castration-resistant PCa

May 20, 2013

The FDA has approved radium Ra 223 dichloride (Xofigo) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.

The FDA has approved radium Ra 223 dichloride (Xofigo) injection for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease.

According to manufacturer Bayer HealthCare, radium Ra 223 dichloride is the first and only alpha particle-emitting radioactive therapeutic agent approved by the FDA that has demonstrated improvement in overall survival and delay in time to first symptomatic skeletal event (SSE) compared to placebo, as shown in the pivotal phase III ALSYMPCA trial.

The agent is being approved more than 3 months ahead of its prescription drug user fee goal date of Aug. 14, 2013. Commercial production is under way, and first doses are expected to be ready for patient treatment in June.

"Most men with castration-resistant prostate cancer develop bone metastases, which can decrease overall survival," said Oliver Sartor, MD, of the Tulane Cancer Center, New Orleans, and North American principal investigator for the pivotal trial. "Xofigo has demonstrated an anti-tumor effect on bone metastases and will be an important addition to the treatment of this cancer."

The drug’s approval is based on data from the ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, radium Ra 223 dichloride significantly improved overall survival (HR=0.695 [95% CI: 0.552-0.875], p=.00185). Median overall survival was 14 months with radium Ra 223 dichloride plus best standard of care versus 11.2 months with placebo plus best standard of care. In addition, at the interim analysis there was a delay in time to first SSE for patients treated with the drug versus placebo.

An updated analysis, conducted after the study was unblinded, showed improvement in overall survival, with a median overall survival of 14.9 months versus 11.3 months; HR=0.695 (95% CI: 0.581-0.832).

The most common adverse reactions (≥10%) in patients receiving radium Ra 223 dichloride in the ALSYMPCA trial were nausea, diarrhea, vomiting, and peripheral edema. The most common hematologic laboratory abnormalities (≥10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.

Dr. Sartor has served as a consultant/adviser to Algeta, Bayer HealthCare, and Dendreon.
 

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