The Institute of Cancer Research, London, has strongly welcomed the approval by the European Commission yesterday (Thursday) of the targeted drug olaparib for men with advanced prostate cancers with genetic alterations in BRCA1 or BRCA2.
The approval, based on results from the PROfound trial, will enable men with prostate cancer who have failed to respond to targeted hormone treatments enzalutamide or abiraterone to benefit from olaparib.
It follows a recommendation from the European Medicines Agency (EMA) in September.
Scientists at The Institute of Cancer Research (ICR) discovered how to genetically target olaparib – which became the world’s first cancer drug to be directed against inherited genetic faults when it was approved for use in ovarian cancers.
Since then, it has also been licensed in breast cancer in Europe and the US, and was approved for use in prostate cancer in the US in May earlier this year.
Today’s approval makes olaparib the first genetically targeted drug to be approved for prostate cancer in Europe, bringing it closer to many patients who will now be able to benefit from a more personalised treatment.
The decision follows findings from the landmark PROfound trial, led by the ICR and The Royal Marsden NHS Foundation Trust, showing that olaparib blocked prostate cancer growth more effectively than abiraterone and enzalutamide in men with faulty DNA repair genes.
Olaparib lacks the side effects of chemotherapy because it selectively targets and kills cancer cells with faulty DNA repair machinery.
The precision drug does this by blocking PARP, a protein involved in repairing DNA when it becomes damaged, in cancer cells with BRCA mutations or other genetic faults which have already weakened their DNA repair systems.
The cancer cells are unable to cope with the double blow to their ability to repair DNA, and so die.
The next step is for NICE, which has already started its appraisal process, to approve olaparib for men with prostate cancer, so that patients in England and Wales are able to access it as soon as possible.
Professor Johann de Bono, Professor of Experimental Cancer Medicine at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, led the PROfound trial. He said:
“I’m really pleased to see olaparib, a drug that cleverly targets a specific genetic weakness, being licensed by the European Commission for men with advanced prostate cancer. I’m now keen to see NICE follow suit as soon as possible, so that men in England, Wales and elsewhere in the UK can access this highly innovative new treatment, which is capable of changing lives.”
Professor Paul Workman, Chief Executive of The Institute of Cancer Research, London, said:
“It’s fantastic to see that the EU has now followed the US in approving use of olaparib for some men with prostate cancer.
“Olaparib is a great UK success story, and a perfect example of putting science into action to help patients.
We’re proud to have discovered how to genetically target olaparib here at the ICR and to have worked with our colleagues at The Royal Marsden on many of the key clinical trials. It’s great to see the drug now helping cancer patients all over the world to live longer and achieve a better quality of life.”
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