Astellas' Prostate Cancer Drug Receives Priority FDA Approval
Posted 04 September 2012 | By
A new drug manufactured by California-based Astellas Pharma promises to help treat aggressive, late-stage prostate cancer that has evaded other treatments, the US Food and Drug Administration (FDA) said in a statement approving the drug on 31 August.
The drug, Xtandi (enzalutamide), was approved under FDA's priority review program, and was reviewed in just three months-half the time allotted to FDA under the priority review program.
Xtandi was subject to a clinical trial of 1,199 patients who had previously received docetaxel, an alternate prostate cancer treatment. The results of the trial showed a statistically significant improvement increase in the patients' overall survival rate from 13.6 months with no treatment to 18.4 months for those receiving Xtandi.
"The need for additional treatment options for advanced prostate cancer continues to be important for patients," said Richard Pazdur, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. "Xtandi is the latest treatment for this disease to demonstrate its ability to extend a patient's life."
FDA regulators highlighted the potential for patients receiving the drug to suffer from seizures, which it said occurred in seven (.875%) patients enrolled in the study. Other side effects included muscle pain or weakness, high blood pressure, joint pain, musculoskeletal pain and upper respiratory infections.
FDA - FDA approves new treatment for a type of late stage prostate cancer
Drugs @ FDA - Label Information for XtandiFDA - Enzalutamide (XTANDI Capsules)