The Scottish Medicines Consortium (SMC) has approved the restricted use of Janssen’s prostate cancer drug Zytiga (abiraterone acetate).

The treatment has been recommended as a treatment option for men with metastatic castration resistant prostate cancer who have received only one prior chemotherapy regimen.

Zytiga – which was discovered in the UK – has been shown to prolong the life of some patients by nearly five months when compared with placebo plus low dose prednisolone in clinical trials.

Martin Price, External Affairs Director at Janssen UK, said the pharmaceutical company had gone to “significant lengths” to find a solution that allows patients to be treated with the drug.

Annually there are more than 40,000 men diagnosed with prostate cancer in the UK. More than 10,000 men die of the disease – making prostate cancer the second most common cause of cancer deaths.

Dr Rob Jones, Senior Lecturer and Hon Consultant in Medical Oncology, Beatson West of Scotland Cancer Centre, called the decision to approve the restricted use of Zytiga “very good news”.

The treatment was approved for use in the NHS in England when NICE reversed its original recommendation back in June after Janssen had agreed a Patient Access Scheme with the DH.

NICE’s decision to recommend the use of Zytiga (abiraterone) in final guidance to treat prostate cancer has left Janssen “delighted”.

The treatment originally failed to get backing from NICE in combination with prednisone or prednisolone after the Institute deemed it to be too expensive – despite its clinical benefits.

However, after Janssen provided additional patient data and a revised Patient Access Scheme (PAS), NICE said it was happy to recommend the treatment as an option for the NHS.

Martin Price, External Affairs Director, Janssen UK, said the company had gone to “significant lengths” to find a solution that allows patients to be treated with the “innovative, UK discovered medicine, routinely on the NHS”.

The decision to recommend the treatment has also been backed by Dr Heather Payne, Consultant Clinical Oncologist, University College London Hospitals. She commented: “This is good news for patients – for whom historically there have been few treatment options available – and also for the patients’ families.”

Zytiga may potentially extend the lives of patients by more than three months. It is now recommended in combination with prednisone or prednisolone as a treatment option for castration-resistant metastatic prostate cancer that has progressed on or after one docetaxel-containing therapy.

NICE’s decision to recommend Janssen’s prostate cancer drug Zytiga (abiraterone) has been backed by patient groups.

Zytiga is now recommended in new draft guidance after further patient data and a revised Patient Access Scheme (PAS) convinced NICE to reconsider its previous rejection of the drug.

Dr Harpal Kumar, CEO of Cancer Research UK, said the decision is “wonderful news for patients” and believes the U-turn reflects “the public’s disappointment at the initial refusal”.

In February this year, NICE failed to recommend the treatment in combination with prednisone or prednisolone after deeming it to be too expensive – despite its clinical benefits.

At the time of the decision, Janssen said it would work closely with NICE to gain a positive recommendation. That included supplying a revised PAS and additional data on a subgroup of patients who may receive the most benefit from the cancer drug.

Janssen also submitted further information on the number of patients for whom Zytiga is licensed, enabling it to be considered under NICE’s end of life criteria.

Professor Johann de Bono from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, who led the pivotal trials of Zytiga, said he was “thrilled” the revised data has changed NICE’s original decision.

“Abiraterone acetate is one of only a handful of life-extending drugs for these men in the UK and, importantly, it can also improve quality of life,” he said. “Some of my patients have been taking abiraterone for several years through a clinical trial and are still pain free.”

Prostate cancer is the second most common cause of cancer deaths in UK men. More than 10,000 men die each year with a further 40,000 men diagnosed annually.

Patients in Wales may soon be prescribed Zytiga (abiraterone acetate) for the treatment of metastatic castration resistant prostate cancer – weeks after NICE failed to recommend its use.

The All Wales Medicines Strategy Group recommend the treatment’s use in a positive final appraisal after Phase III data showed it improved median overall survival by 4.6 months.

Professor John Wagstaff, Personal Professor & Clinical Senior Lecturer in Oncology, Swansea University College of Medicine, says the approval is a “significant step forward” for men with the disease.

NICE came under attack from Cancer Research UK, who helped co-develop the drug, after it deemed the treatment to be too expensive to use on the NHS earlier this month in draft guidance.

Zytiga is indicated with prednisone or prednisolone for the treatment of metastatic castration resistant prostate cancer in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.

It has been shown to prolong life in the post-chemotherapy treatment of some men with metastatic prostate cancer that has spread to other parts of the body, and then progressed after developing resistance to conventional hormonal therapies. Currently, there are few treatment options for patients in this stage of the disease.

“The availability of this medicine goes a long way towards fulfilling an important unmet need,” said Professor Wagstaff. “In my experience of using abiraterone acetate in the clinical trials programme, this medicine has both the potential to extend life, and also to improve a patient’s quality of life.”

Around 37,000 men in the UK are diagnosed with prostate cancer in the UK each year with around 10,000 deaths a year.

The marketing authorisation for Zytiga (abiraterone acetate) has been approved by the European Commission after an accelerated regulatory review process by the EMA.

The androgen biosynthesis inhibitor has been approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) whose disease has progressed.

Professor Karim Fizazi, Department of Cancer Medicine, Institute Gustave Roussy, France, says its approval “gives new hope to men” suffering from the disease across Europe.

The fast-track review by the EMA followed a positive opinion by the CHMP in July.

Zytiga demonstrated in a pivotal Phase III study a 35.4% reduction in the risk of death and an improvement of almost four months in median overall survival.

“The efficacy, safety and ease of use of abiraterone acetate, a medicine that can be taken at home, will address an important unmet medical need for many patients, helping them to live longer with a better quality of life and less pain,” added Professor Fizazi.

Prostate is the third most common cause of cancer deaths in Europe. An estimated 370,000 new cases were diagnosed across Europe, resulting in the deaths of nearly £90,000 men.

The CHMP has recommended the approval of Zytiga (abiraterone acetate) for the treatment of progressed prostate cancer or after docetaxel-based chemotherapy for the disease.

The recommendation is based on a Phase III trial that showed Zytiga, in combination with prednisone or prednisolone, improved overall survival in men suffering with the disease.

Jane Griffiths, Company Group Chairman of Janssen Europe, says the company is working with health regulators to ensure the treatment “becomes available as quickly as possible to patients”.

The CHMP’s recommendation has now been referred to the European Commission for approval.

Zytiga, a once-daily, oral, androgen biosynthesis inhibitor, was approved in the US by the FDA in April 2011.

In 2008, an estimated 370,000 new cases of prostate cancer were diagnosed in Europe, and nearly 90,000 men died from the disease.