Bayer’s Nubeqa combo approved in Europe for non-metastatic castration-resistant prostate cancer
pharmafile | March 31, 2020 | News story | Manufacturing and Production, Research and Development | Bayer, Cancer, Europe, Nubeqa, prostate cancer
The European Commission has given the green light to Bayer’s non-steroidal androgen receptor inhibitor Nubeqa (darolutamide), jointly developed with Orion, in the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC) in men who are at high risk of developing metastatic disease.
Phase 3 data supporting the approval showed that Bayer’s drug, in combination with androgen deprivation therapy (ADT), improved metastasis-free survival by a median of 40.4 months compared to just 18.4 months with placebo plus ADT, meeting the trial’s primary goal.
Furthermore, the data showed a positive trend for overall survival – a secondary endpoint of the trial – but the data had not reached maturity; an update on these data, other endpoints and long-term safety data are due to be presented at a future medical meeting.
“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,” explained Dr Melissa Rowe, Director of Medical Affairs for Specialty Medicine at Bayer UK. “This authorisation represents a meaningful advancement in the fight against prostate cancer.”
The drug has already secured approval in the US, Japan and Brazil, with reviews in other regions either in the pipeline or already underway.
Matt Fellows
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