FDA expands Pfizer and Astellas' Xtandi into castration-resistant prostate cancer

Astellas and Pfizer have revealed that their androgen receptor inhibitor Xtandi (enzalutamide) has received approval from the FDA to expand its label indications to include the treatment of metastatic castration-resistant prostate cancer (CRPC).

The decision means that Xtandi is now the first and only oral therapy approved in the US in both metastatic and non-metastatic CRPC. The move was based on Phase 3 results showing that, when used in combination with androgen deprivation therapy (ADT), Xtandi significantly reduced the risk of developing metastasis or death compared to ADT alone in men with non-metastatic CRPC, while median metastasis-free survival (MFS) – the study’s primary endpoint – was 36.6 months for the combo, compared to 14.7 months

 "With today's approval, there is now a new option for men with non-metastatic CRPC, who are in between the failure of androgen deprivation therapy resulting in CRPC and the onset of metastatic disease," remarked Dr Jonathan Simons, Prostate Cancer Foundation President and CEO. "As a foundation that drives research aimed at improving patient outcomes, it is exciting to see approvals like this, which are vital to help address unmet patient needs." 

Xtandi was originally approved by the FDA in 2012 for metastatic CRPC in patients previously treated with docetaxel.

"Reducing the risk of disease progression is an important treatment goal in castration-resistant prostate cancer, since the disease becomes harder to treat as it advances," said Andy Schmeltz, Global president, Oncology at Pfizer. "With Xtandi, men with CRPC now have a clinically proven treatment option that reduces the risk of metastasis. This approval delivers on the potential for Xtandi to help men at an earlier stage of the disease, and we are continuing to evaluate the medicine in an extensive development programme across additional prostate cancer populations." 

Dr Steven Benner, Senior Vice President and Global Therapeutic Area Head, Oncology Development, at Astellas, also added: "This approval is important progress for men with CRPC, who now have XTANDI as a treatment option regardless of whether or not they have detectable metastatic disease. Xtandi is a standard of care in the treatment of men with metastatic CRPC and has been prescribed to more than 250,000 men worldwide since its initial approval in 2012. The expanded indication based on the PROSPER data builds on the body of evidence for Xtandi."

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