Astellas, Pfizer bag Xtandi FDA approval for non-metastatic CRPC

In a significant development, Astellas Pharma and Pfizer have announced that the U.S. Food and Drug Administration (FDA) has expanded the approval of their cancer drug Xtandi (enzalutamide) for the treatment of men with non-metastatic castration-resistant prostate cancer (CRPC). This marks an important step forward in the treatment options available to patients suffering from this challenging stage of prostate cancer.

Initially approved in 2012 for the treatment of metastatic CRPC in patients who had previously undergone docetaxel therapy, Xtandi received subsequent approval in 2014 for use in chemotherapy-naïve men with castration-resistant prostate cancer. The latest approval makes Xtandi the first oral medication approved for both metastatic and non-metastatic CRPC.

The recent expansion of Xtandi’s approval is based on the results from the PROSPER phase 3 clinical trial. The study demonstrated that Xtandi, in combination with androgen deprivation therapy (ADT), significantly reduced the risk of developing metastasis or death compared to ADT alone in men with non-metastatic CRPC. Jonathan Simons, President and CEO of the Prostate Cancer Foundation, highlighted the approval as providing a crucial new treatment option for men at a critical juncture of their disease progression.

Andy Schmeltz, Global President of Oncology at Pfizer, emphasized the difficulty in treating CRPC as it advances and noted that reducing disease progression remains a primary treatment goal. “With Xtandi, men with CRPC now have a clinically proven treatment option that reduces the risk of metastasis,” Schmeltz commented, underscoring the drug’s potential benefits in earlier stages of the disease.

The expansion of Xtandi’s FDA approval is a vital advancement in prostate cancer treatment. By targeting earlier stages of CRPC, Xtandi offers hope for better patient outcomes and highlights the ongoing commitment to researching and developing more effective cancer treatments.