Astellas’ Xtandi bags additional MHRA approval in prostate cancer

Japanese pharma company Astellas has announced that its prostate cancer therapy Xtandi has gained an approval for an additional indication from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

The additional indication is for once-daily oral Xtandi (enzalutamide) for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC).

Following this new approval, Xtandi becomes the only oral treatment approved by the MHRA for three types of advanced prostate cancer, including high-risk non-metastatic and metastatic castration-resistant prostate cancer and mHSPC.

“[Xtandi] has been an established standard of care for men with advanced prostate cancer and has been prescribed to more than 610,000 patients worldwide since it was first approved in 2012,” said Andrew Krivoshik, senior vice president and global therapeutic area head, oncology development, Astellas.

“This new indication for [Xtandi] provides men with mHSPC a much-needed, additional therapy option earlier in their treatment journey,” he added.

The new indication approval is based on results from the Phase III ARCHES trial, which evaluated Xtandi in men with mHSPC.

This trial showed that Xtandi plus androgen deprivation therapy (ADT) reduced the risk of radiographic progression or death by 61% compared with placebo plus ADT in men with mHSPC.

Safety analyses of this trial also appeared consistent with the safety profile of Xtandi in previous CRPC trials, with grade 3 or greater adverse events found to be similar for patients receiving both Xtandi plus ADT and those receiving placebo plus ADT – 24.3% versus 25.6%, respectively.

“Metastatic hormone-sensitive prostate cancer patients have limited options and, unfortunately, there is a poor prognosis for many men,” said Andrew Armstrong, professor of medicine, surgery, pharmacology and cancer biology, director of research in the Duke Cancer Institute’s Center for Prostate and Urologic Cancers and lead investigator of ARCHES.

“The research supporting this approval provides clinical evidence showing how [Xtandi] can help improve outcomes for men with mHSPC, which gives healthcare professionals in Europe the option to offer the treatment across the advanced prostate cancer disease continuum,” he added.