FDA approves sNDA for Xtandi capsules in advanced prostate cancer

Data demonstrate improvement in radiographic progression-free survival in patients with metastatic castration-resistant prostate cancer who were treated with enzalutamide compared to patients who were treated with bicalutamide.

The TERRAIN study evaluated men with metastatic CRPC and the results from this study were published in the Lancet Oncology. The updated label includes data that enzalutamide reduces the risk of radiographic progression or death by 40% compared with bicalutamide, showing a median rPFS of 19.5 months for the enzalutamide group versus a median of 13.4 months for the bicalutamide group based on an analysis recommended by the FDA. The safety profile of enzalutamide was consistent with results of earlier enzalutamide trials.

"The addition of data from the TERRAIN trial continues to build the body of evidence that demonstrates the clinical impact Xtandi can have for patients living with metastatic CRPC," said Steven Benner, senior vice president, therapeutic area head for oncology development, Astellas. "Advances in scientific knowledge as seen through clinical trials like TERRAIN would not be possible without the participation of hundreds of patients, family members and clinical investigators, and we thank them for their valuable contributions."

"We are pleased with the FDA's decision to update the Xtandi label with these data from the first and largest comparative trial that demonstrated safety and efficacy of enzalutamide compared to bicalutamide," said Mohammad Hirmand, interim chief medical officer at Medivation, which is now part of Pfizer. "We believe these data will help physicians better understand the differences between enzalutamide and bicalutamide for their patients living with metastatic CRPC."