US FDA approves sNDA for XTANDI in advanced prostate cancer

24 October 2016 (Last Updated October 24th, 2016 18:30)

Astellas Pharma and Pfizer have announced that the US Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the product labelling for XTANDI (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study.

Astellas Pharma and Pfizer have announced that the US Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the product labelling for XTANDI (enzalutamide) capsules to include new clinical data versus bicalutamide from the TERRAIN study.

This data indicates improvement in radiographic progression-free survival (rPFS) in patients suffering with metastatic, castration-resistant prostate cancer (CRPC) who were treated with enzalutamide compared to patients who were treated with bicalutamide.

The study analysed men with metastatic CRPC. The updated label has data that enzalutamide cuts down the risk of radiographic progression or death by 40% compared with bicalutamide. This indicates 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 the results of previous enzalutamide study.

"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 senior vice president and therapeutic area head for oncology development Steven Benner said: “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.

“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.”

Every year, approximately 181,000 new cases of prostate cancer will be diagnosed and an estimated 26,000 men will die of the disease in 2016, according to the American Cancer Society.

Up to 40% of men diagnosed with prostate cancer who undergo therapy develop metastatic or advanced prostate cancer.

The five-year relative survival rate for prostate cancer patients with metastatic disease is 28%, compared with 100% for prostate cancer patients with non-metastatic disease in the US.