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Bayer receives authorisation in Europe for NUBEQA®▼(darolutamide), a new treatment for men with non-metastatic castration-resistant prostate cancer


  • Oral androgen receptor inhibitor (ARi) NUBEQA® (darolutamide) authorised for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease
  • European authorisation is based on Phase III ARAMIS trial data showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT, and darolutamide’s safety profile to date1

Reading, 31 March, 2020The European Commission has granted marketing authorisation in the European Union (EU) for the new prostate cancer treatment NUBEQA® (darolutamide), a non-steroidal androgen receptor inhibitor (ARi).2 The compound is licensed for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.2 The oral androgen receptor inhibitor (ARi) is already authorised in the U.S., Brazil and Japan and filings in other regions are underway or planned.

This decision is based on the positive results of the Phase III ARAMIS trial evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT, which demonstrated a significant improvement in the primary efficacy endpoint of metastasis-free survival (MFS) of darolutamide plus ADT, with a median 40.4 months, versus 18.4 months for placebo plus ADT (p<0.001) and darolutamide’s safety profile to date.1,2

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. Bayer is responsible for global commercialisation, with a co-promotion of Bayer and Orion Corporation in certain European markets, e.g. in France, Germany, Italy, Spain, the UK, Scandinavia and Finland.

Professor Heather Payne, Consultant in Clinical Oncology at University College Hospital, London, said “Men with nmCRPC typically have no symptoms, so it is important to have treatment options that delay the progression of their cancer and minimise the challenging side effects of treatment to allow them to go about their everyday lives.”

“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 (nmCRPC).3 In Europe over 67,000 men are estimated to have a CRPC diagnosis, based on 2018 prostate cancer incidence numbers.3,4 About one-third of men with nmCRPC go on to develop metastases within two years.3

In the ARAMIS trial, overall survival (OS) and time to pain progression were secondary efficacy endpoints.1,2 At the time of final MFS analysis, a positive trend in OS was observed; OS data were not yet mature.2 Detailed data on the updated OS and other endpoints as well as an update on longer term safety will be presented at an upcoming scientific meeting.  The MFS result was supported by a delay in time to pain progression as compared to placebo plus ADT.2 All other secondary endpoints, time to cytotoxic chemotherapy, and time to a symptomatic skeletal event (SSE), also demonstrated a benefit in favour of darolutamide at the time of final MFS analysis.1

The most frequent adverse reactions in the darolutamide plus ADT arm, that occurred with an absolute increase in frequency of ≥3% compared to placebo plus ADT, were fatigue/asthenic conditions (15.8% vs. 11.4%), fractures (4.2% vs 3.6%), neutrophil count decrease (19.6% vs 9.4%), bilirubin increase (16.4% vs 6.9%), AST increase (22.5% vs 13.6%), pain in extremity (5.8% vs. 3.2%), rash (2.9% vs. 0.9%) and cardiological disorder (3.2% vs 2.5%).1,2 Discontinuation due to adverse events occurred in 8.9% of darolutamide group and 8.7% in the placebo group.1,2

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Last Updated: 01-Apr-2020