Astellas has announced that its Pfizer-partnered androgen receptor signalling inhibitor Xtandi (enzalutamide) has been approved by the European Commission (EC) for expanded prostate cancer use.
The drug has been authorised for use as a monotherapy or in combination with androgen deprivation therapy (ADT) in adults with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.
The regulator’s decision makes Xtandi, which is already approved in the EU for castration-resistant prostate cancer and metastatic hormone-sensitive prostate cancer, the first hormone therapy available in the EU to treat this subset of patients.
Compared with Xtandi’s previously-approved indications, nmHSPC represents an earlier stage of disease. In nmHSPC, there is no detectable evidence of the cancer spreading to distant parts of the body (metastases) and the disease still responds to testosterone-lowering treatments.
However, up to 40% of patients who have undergone definitive prostate cancer treatment will experience BCR within ten years, and about nine out of ten of those with high-risk BCR will develop metastatic disease.
The extended approval of Xtandi follows a recent recommendation from the European Medicines Agency’s human medicines committee and is supported by positive results from the phase 3 EMBARK trial.
Results showed that patients treated daily with Xtandi plus the gonadotropin-releasing hormone (GnRH) agonist leuprolide had a 57.6% lower chance of their cancer spreading or dying compared to those treated with leuprolide alone, while those receiving Xtandi monotherapy had a 36.9% reduction in risk.
Ahsan Arozullah, senior vice president and head of oncology development at Astellas, described the expanded approval as a “vitally important advance” for patients with nmHSPC and high-risk BCR.
Arozullah continued: “Efficacy and safety results from the EMBARK study demonstrate the potential for Xtandi as a new option for treatment in the early, recurrent hormone-sensitive prostate cancer setting.
“Astellas is in active discussions with regulatory authorities around the world to bring Xtandi to those who may benefit.”
The EC’s decision comes five months after Xtandi was approved by the US Food and Drug Administration, for use with or without a GnRH analog therapy to treat non-metastatic castration-sensitive prostate cancer (nmCSPC) patients with BCR at high risk for metastasis.