The European Commission has granted marketing authorisation in the European Union (EU) for Bayer’s Nubeqa (darolutamide), for certain men with non-metastatic castration-resistant prostate cancer (nmCRPC).
According to the company, the European authorisation is based on Phase III ARAMIS trial data showing a statistically significant improvement in metastasis-free survival (MFS) for the drug in combo with androgen deprivation therapy (ADT).
The non-steroidal androgen receptor inhibitor compound is now licensed for the treatment of men who are at high risk of developing metastatic disease, having already been authorised in the US, Brazil and Japan, with filings in other regions underway or planned.
In the trial, the drug, which is developed jointly by Bayer and Orion Corporation, demonstrated a significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS), with a median outcome of 40.4 months, versus 18.4 months for placebo plus ADT.
“With the authorisation of darolutamide in the EU, physicians in Europe now have a new therapeutic option with generally manageable side effects that delays the development of metastases in men with prostate cancer when compared to placebo and ADT alone. This authorisation represents a meaningful advancement in the fight against prostate cancer.” said Dr Melissa Rowe, director of medical affairs for Specialty Medicine at Bayer UK.
Prostate cancer that is confined to the prostate region and is treated with ADT but keeps progressing, even when the amount of testosterone is reduced to very low levels in the body, is known as non-metastatic CRPC
Bayer reminds that in Europe over 67,000 men are estimated to have a CRPC diagnosis, based on 2018 prostate cancer incidence numbers.