A life-extending new drug to treat patients with advanced prostate cancer, developed by The Institute of Cancer Research (ICR) and The Royal Marsden Hospital, has now received its UK license.
There are calls for the drug, abiraterone acetate, which is marketed by Janssen under the trade name Zytiga, to receive a speedy decision from the National Institute for Health and Clinical Excellence (NICE) on whether it should be made routinely available to all appropriate patients.
The once-daily pill has now been launched in the UK, after the European Commission approved it earlier this month for the treatment of metastatic prostate cancer. It is licensed for use in combination with the steroids prednisone or prednisolone by men whose disease has developed resistance to conventional hormone therapies and docetaxel-based chemotherapy.
An estimated 10,500 men in the UK have advanced prostate cancer that has become resistant to standard hormone treatments.
Abiraterone acetate is a new type of treatment for prostate cancer that works by blocking the synthesis of testosterone in all tissues including the tumour itself, not just the testes; this testosterone would otherwise continue to fuel prostate cancer growth and spread.
The drug was discovered at the ICR in what is now the Cancer Research UK Cancer Therapeutics Unit and further developed at the ICR and The Royal Marsden, and its launch is "the culmination of immense hard work and dedication by scientists and clinicians here and around the world," said the ICR's chief executive, Professor Alan Ashworth.
"To have reached the point where thousands of prostate cancer patients will be able to benefit from this life-extending treatment is hugely rewarding," added Prof Ashworth, while The Royal Marsden's chief executive, Cally Palmer, noted that the drug’s development by the Hospital and the ICR "highlights the national importance of funding pioneering cancer research. We are delighted our patients at The Royal Marsden have been among the first to benefit from the very latest in drug development."
Results of a major international Phase III trial of almost 2,000 men, led jointly by Professor Johann de Bono from the ICR and The Royal Marsden, showed that patients given abiraterone lived on average 15.8 months compared to 11.2 months for men taking a placebo. Pain also eased for a higher proportion of patients taking abiraterone, while side effects were easily manageable and reversible.
Prostate cancer kills one man each hour in the UK, so there is a need for new therapies, commented Prof de Bono, who said he was "pleased to have this important new treatment option available for my patients who are no longer responding to standard drugs."
Cancer Research UK's chief executive Harpal Kumar also welcomed abiraterone's launch in the UK, especially, he said, “given the role Cancer Research UK played in the early stages of its development."
NICE must now decide as quickly as possible whether the drug should be made routinely available to all appropriate patients and, in the meantime, decisions about whether patients can be given it will have to be made locally or through the Cancer Drugs Fund, said Mr Kumar.
"It's important that promising new drugs are made available to patients who need them, and we look forward to the NICE decision on this drug which we hope will help improve survival for men with this disease," he added.