
Bayer’s Xofigo wins FDA approval for treatment of metastatic prostate cancer
The IV injectable treatment is easy to administer and has been shown to prolong survival in patients with CRPC.
FDA has approved radium Ra 223 dichloride (
“What’s most important is the efficacy benefit to patients,” said Shannon Campbell, vice president & general manager, oncology at Bayer HealthCare Pharmaceuticals. “Xofigo is the first and only alpha particle-emitting radioactive therapeutic agent approved by FDA that has demonstrated improvement in overall survival [OS] and delay in time to first symptomatic skeletal event [SSE] compared to placebo. These are crucial benefits, as bone metastases are the main cause of morbidity and death in patients with CRPC.”
In addition, Xofigo is easy to administer - given as a patient-specific ready-to-use intravenous injection administered by a slow IV injection over one minute in an outpatient hospital or clinic setting,” Campbell added. “Patients may return home shortly after the Xofigo injection, with no restrictions on interpersonal contact.”
Xofigo, or radium-223, mimics calcium and targets areas of high bone turnover at the site of bone metastases. It attacks a tumor where it lives in the bone while limiting damage to the surrounding normal tissues.
Xofigo is the second drug with the potential to extend survival in patients with metastatic prostate cancer approved by FDA in the past year.
In August 2012 FDA approved enzalutamide (
According to the
Prostate cancer incidence rates rose dramatically in the late 1980s, when
Xofigo is being approved more than 3 months ahead of the product’s prescription drug user fee goal date of August 14, 2013, the date the agency was scheduled to complete its review of the drug application. FDA reviewed Xofigo under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products.
The approval of Xofigo is based on data from the pivotal phase 3 ALSYMPCA (ALpharadin in SYMptomatic Prostate CAncer) trial. At the interim analysis, Xofigo significantly improved overall survival (OS) [HR=0.695 (95% CI, 0.552–0.875); P=.00185]; median OS was 14 months with Xofigo 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 symptomatic skeletal event (SSE) for patients treated with Xofigo versus placebo.
An updated analysis, conducted after the study was unblinded, showed improvement in overall survival (OS), with a median OS of 14.9 months versus 11.3 months; HR=0.695 (95% CI, 0.581–0.832).
The most common adverse reactions (greater than or equal to 10%) in patients receiving Xofigo in the ALSYMPCA trial were nausea, diarrhea, vomiting, and peripheral edema. The most common hematologic laboratory abnormalities (greater than or equal to 10%) were anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia.
For a snapshot of prostate cancer presented at the National Cancer Institute website,
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