Pfizer and Astellas have announced phase III clinical trial data showing the benefits that Xtandi can offer in the treatment of prostate cancer.

Data from the PROSPER trial have shown that Xtandi, when added to androgen deprivation therapy (ADT), was able to improve metastasis-free survival rates in patients with non-metastatic castration-resistant prostate cancer (CRPC), compared to ADT alone.

“Pfizer and Astellas has reported new clinical data showing the effectiveness of Xtandi in the treatment of non-metastatic castration-resistant prostate cancer.“

Meanwhile, a preliminary safety analysis of the PROSPER trial appeared consistent with the safety profile of Xtandi established in previous clinical trials.

Xtandi is the first androgen receptor inhibitor to demonstrate a statistically significant improvement in metastasis-free survival in this patient population in a randomised, controlled clinical trial.

Dr Mace Rothenberg, chief development officer for oncology at Pfizer's global product development unit, said the results show that the treatment "delayed clinically detectable metastases compared to ADT alone in patients with non-metastatic CRPC whose only sign of underlying disease was a rapidly rising prostate-specific antigen level".

The companies intend to discuss the data from this trial with global health authorities to potentially support expanding the label for Xtandi to cover all patients with CRPC.

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