Astellas’ Xtandi receives final draft recommendation from NICE

Astellas' enzalutamide-based prostate cancer therapy Xtandi has received a provisional recommendation from the UK's National Institute for Health and Care Excellence (NICE).

According to final draft guidance from the UK regulator, people with hormone-relapsed prostate cancer that has spread to other parts of the body and have already been treated with docetaxel should be given access to Xtandi via the NHS.

Previously, NICE had not recommended Xtandi to those who had previously been treated with abiraterone, but this stipulation has now been removed from the guidance, following a consultation.

Astellas has provided the committee with new observational studies showing how enzalutamide works in patients who received previous treatment with abiraterone. It has been mutually decided that a firm decision on the use of the drug in these circumstances cannot be made on current evidence.

Professor Carole Longson, director of the centre for health technology evaluation at NICE, said: "We know that the manufacturer is currently collecting data on the use of enzalutamide after abiraterone and we look forward to seeing the results of the ongoing trials."

This comes in the same week that Astellas received priority review status for Xtandi from the US Food and Drug Administration.