Pfizer and Astellas have announced that their androgen receptor signalling inhibitor, Xtandi (enzalutamide), has been granted priority review by the US Food and Drug Administration (FDA) to treat patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with high-risk biochemical recurrence (BCR).
The treatment is already a standard of care in the US for metastatic castration-sensitive prostate cancer, metastatic castration-resistant prostate cancer and non-metastatic castration-resistant prostate cancer, and for one or more of these indications in more than 100 countries.
Compared with those indications, nmCSPC represents an earlier stage of disease, in which there is no detectable evidence of the cancer spreading to distant parts of the body, and it still responds to testosterone-lowering treatments.
However, some patients remain at a higher risk for BCR following primary treatment, which may result in metastases.
The companies’ supplemental new drug application for Xtandi is supported by positive results from the phase 3 EMBARK trial, which demonstrated a statistically significant and clinically meaningful improvement in metastasis-free survival (MFS) for high BCR risk nmCSPC patients treated daily with Xtandi plus leuprolide versus placebo plus leuprolide.
The study also met a key secondary endpoint of a statistically significant and clinically meaningful improvement in MFS for those treated with Xtandi monotherapy versus placebo plus leuprolide.
Chris Boshoff, chief oncology research and development officer, executive vice president at Pfizer, said: “The FDA’s granting of a priority review designation reinforces the need to bring new treatment options for patients with high-risk biochemical recurrent nmCSPC.
“We believe the EMBARK data demonstrates the potential of Xtandi, if approved, to help patients earlier in the course of their disease, building on Xtandi’s foundation as an existing standard of care in prostate cancer.”
The companies outlined that the data from EMBARK is also being discussed with other regulatory authorities to support a potential submission for Xtandi in this indication.
Ahsan Arozullah, senior vice president and head of oncology development at Astellas, said: The addition of Xtandi to leuprolide has shown greater clinical benefit compared to placebo plus leuprolide, and we look forward to working with the FDA and other global regulatory authorities to bring Xtandi to these patients.”