FDA approves supplemental NDA for Xtandi in castration-sensitive prostate cancer.- Pfizer + Astellas

Pfizer and Astellas Pharma announced that the FDA has approved a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). With this approval, Xtandi is now the first and only oral treatment approved by the FDA in three distinct types of advanced prostate cancer � non-metastatic and metastatic castration-resistant prostate cancer (CRPC) and mCSPC. The approval is based on results from ARCHES, a randomized Phase III study which evaluated 1,150 men with mCSPC and met its primary endpoint of radiographic progression-free survival (rPFS).

Data from the ARCHES trial demonstrated that the use of Xtandi plus androgen deprivation therapy (ADT) significantly reduced the risk of radiographic progression or death by 61 percent compared to placebo plus ADT (n=1,150; hazard ratio [HR]: 0.39 [95% confidence interval (CI): 0.30-0.50]; p<0.0001). overall survival data were not mature at the time of final rpfs analysis. the safety analysis of the arches trial is generally consistent with the safety profile of xtandi in previous clinical trials in crpc. in arches common adverse reactions grade 1 to 4 ars occurring in at least 5 of patients that were reported more frequently in patients treated with xtandi plus adt vs placebo plus adt included hot flush 27 vs 22 asthenic conditions 24 vs 20 hypertension 8.0 vs 5.6 fractures 6.5 vs 4.2 and musculoskeletal pain 6.3 vs 4.0.>

Comment: In 2019, it is estimated that just over 40,000 men in the United States are living with mCSPC, a form of prostate cancer that has spread to other parts of the body and still responds to a medical or surgical treatment that lowers testosterone.