Delays in releasing a prostate cancer drug are putting lives needlessly at risk, says a father diagnosed with the disease.
Enzalutamide, developed with the help of North East clinical trials, is one of the few treatments shown to extend the lives of men with advanced prostate cancer after standard hormone therapy and chemotherapy has been tried.
Yet access to the treatment will now be delayed after the National Institute for Health and Care Excellence (Nice) has issued second draft guidance for the pioneering treatment.
The move is a major blow and disappointment to many prostate cancer patients in the North East who would benefit from Enzalutamide now.
Father-of-two Mike Ridley-Smith was diagnosed with advanced prostate cancer in July last year. The delays were devastating for the married 56-year-old as the cancer has also spread to his lymph nodes.
The business development manager, of Jesmond, Newcastle, said: “I am very disappointed that a decision on the drug has been delayed as no price should be put on a life.
“A year ago I had no idea that my world would change so dramatically. By delaying a decision lives are being put at risk as patients should have the option to try this drug if they want to.
“I would hope that Nice will give their final outcome soon.”
Last year, data from a major trial showed that the new pill, costing around £2,500 a month, can extend the lives of patients no longer being treated by almost five months.
A clinical trial into the drug was undertaken at the Northern Centre for Cancer Care, based at Newcastle’s Freeman Hospital.
Seven out of 10 of the men in the Phase III Affirm trial taking Enzalutamide, were still alive after one year. The drug blocks molecular signals that allow the male hormone testosterone to fuel prostate cancer. It targets three different steps of the signalling pathway.
Nice has issued a second Appraisal Consultation Document for the use of Enzalutamide which will delay access to the treatment.
The revised draft guidance recommends the drug for use on the NHS as an option for the treatment of hormone-relapsed metastatic prostate cancer in adult patients only if their disease has progressed during or after other courses of treatment have been tried.
A major advantage of Enzalutamide over other treatments is its relative lack of side effects.
Rakesh Heer, consultant urologist at Newcastle’s Freeman Hospital, with an interest in prostate cancer, said: “It is a little bit of a surprise that an exciting drug like Enzalutamide has been delayed for patients. We know that the drug can extend lives and does not have the same side effects as chemotherapy and other lines of treatment.
“Clinicians have been looking forward to using this drug as evidence looks particularly good for it. The safety profile of Enzalutamide appears good and does offer a lot of patients a very effective treatment.”
Karen Verrill, head at Maggie’s North East cancer centre, said: “When new drugs are in the pipeline those who would benefit from them have a lot of hope that the drug will become available.
“When there is a delay it impacts massively on the patient and their family as they pin all their hopes on the approval of the drug. Any delay is devastating for them.”