FDA’s approval of an expanded indication for a prostate cancer drug could net 2 pharmaceutical manufacturers billions of dollars.
FDA broadened the indication for enzalutamide (Xtandi, Astellas Pharma and Pfizer) to include men with non-metastatic castration-resistant prostate cancer (CRPC), making it the first and only FDA-approved oral medication for both non-metastatic and metastatic CRPC.
Xtandi was first approved by FDA in 2012 to treat patients with metastatic CRPC who had previously received docetaxel, and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC.
As a result of the new indication, sales of Xtandi could reach an estimated $4.7 billion in 2022, according to EvalutePharma.
"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,” said Jonathan Simons, MD, president and CEO of the Prostate Cancer Foundation, in a statement from Asetellas and Pfizer.
The expanded approval is based on results from the 2 companies’ phase 3 trial, which demonstrated that the use of Xtandi plus androgen deprivation therapy (ADT) significantly reduced the risk of developing metastasis or death compared to ADT alone in men with non-metastatic CRPC.
The median metastasis-free survival (MFS) was 36.6 months for men who received Xtandi plus ADT compared to 14.7 months with ADT alone.
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