FDA approves XTANDI label update

Astellas Pharma and Pfizer's joint-supplemental New Drug Application that will see the update of the XTANDI capsules product label has been approved by the Food and Drug Administration.
"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," Pfizer interim Chief Medical Officer Dr. Mohammad Hirmand said. "We believe these data will help physicians better understand the differences between enzalutamide and bicalutamide for their patients living with metastatic CRPC."
The updated XTANDI label will feature new data from the TERRAIN trial.
"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," Astellas Head of Oncology Development Dr. Steven Benner said. "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."