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European Medicines Agency approves abiraterone combined with hormone therapy as first-line treatment for advanced prostate cancer


The prostate cancer drug abiraterone has been approved by the European Medicines Agency in combination with standard hormone therapy for use as a first-line treatment for advanced prostate cancer.

Men with newly diagnosed prostate tumours that are ‘high risk’ and have already spread will be eligible for the combination, which was shown to delay progression of the disease by over a year longer than standard hormone treatment alone.

Abiraterone was discovered at The Institute of Cancer Research, London, and had already previously been approved for the treatment of advanced prostate cancer before chemotherapy in men for whom hormone therapy had failed.

The new decision was based on data from the international multicentre phase III LATITUDE trial, which showed that the combination had a clear benefit when used earlier.

NICE is currently carrying out an appraisal for using abiraterone in this setting, and its decision is expected in 2018.

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Drug therapy revolution

Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said:

“It is fantastic news that abiraterone has been approved by the European regulator as a first-line treatment in combination with hormone therapy for men newly diagnosed advanced prostate cancer.

“Drug therapy for prostate cancer has undergone a revolution over the last decade, and this is another big step forward – the first time that a modern, targeted therapy has been approved for use from the point of diagnosis.

“Abiraterone was discovered at the ICR, and has already improved the outlook for hundreds of thousands of men with the disease worldwide. Following fantastic results from clinical trial results published earlier in the year, it is clear that using abiraterone right at the start of treatment can be hugely beneficial – delaying cancer progression by over a year compared with standard hormone therapy alone.

“We hope that NICE and the manufacturer will work together to ensure that abiraterone is made available at an affordable price, so that the combination with hormone therapy can be approved for use on the NHS as soon as possible.”




abiraterone clinical trials Paul Workman prostate cancer NICE European Medicines Agency
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