Zytiga Approved in Ireland

Zytiga has at long last been approved for use in Ireland as from the 1st of December 2012. Initially this treatment, also known as Abiraterone was rejected by the Irish regulatory board NCPE (National Centre for Pharmaco Economics) on cost grounds. However after negotiations with the manufacturer Johnson & Johnson a reduced price has been agreed meaning that this treatment will now be available in Ireland. From 1st of December Zytiga will be available on the national health system for use to treat advanced prostate cancer in men who have relapsed following chemotherapy.

Professor Gerry Potter the inventor of Zytiga has recently been on a lecture tour of Ireland visiting Dublin, Cork and Galway finally giving a public talk to the Ballinasloe Cancer Support Group on the discovery of Zytiga and Salvestrols. After the talk Prof Potter said "I am delighted that men in Ireland can now benefit from Zytiga and all the research that we have done. Hopefully Zytiga will be approved soon for use as an earlier treatment before chemotherapy is even needed".

Medical professionals have hailed the news that Zytiga will soon be available in Ireland as really good news. It can prolong the lives of some of those suffering from the disease. The once-daily oral medication is proven to keep patients alive and improve quality of life for some men in the advanced stages of the disease. Zytiga will be used with a steroid for post- chemotherapy of prostate cancer that has spread to other organs in the body.
It is the second most frequent male cancer and claims the lives of 500 men a year in Ireland alone.
There are almost 17,000 suffering with the disease at the moment and Ireland has the highest incidence in Europe. Consultant oncologist at Tallaght and St Vincent's Hospital Dr Ray McDermott said it is huge progress for prostate cancer sufferers here.
He added: "This is great news for Irish patients and their families.
"Up to now there has been no active treatment available for patients with advanced prostate cancer whose cancer has progressed after chemotherapy so this new treatment represents a real un-met clinical need." The drug will be reimbursed by health authorities here from December 1. John Dowling from the Men Against Cancer said it will give patients precious months more to live.
He added: "Men with advanced prostate cancer, if suitable, may now be offered treatment with abiraterone which may give them the real prospect of precious additional months over current treatments together with a reasonable quality of life."
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In Ireland, prostate cancer is the most frequent cancer in men after non-melanoma skin cancer. There are more than 17,000 men living with prostate cancer in Ireland and approximately 500 die from the disease each year.

Zytiga (abiraterone acetate) was approved originally for patients who had relapsed after multiple forms of ther-apy, including chemotherapy. Approvals following the initial COU-AA-301 Phase III study (the ‘301 Study’) were based on results from an interim analysis showing a statistically significant improvement in overall survival and an acceptable safety profile. Zytiga, in combination with prednisone, was approved by the European Medicines Agency (EMA) in September 2011 for the treatment of metastatic, castration-resistant prostate cancer (mCRPC) in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen.
“As of this moment, abiraterone acetate is not available to patients in Ireland. However, I keenly await its arrival,” Dr Ray McDermott, Consultant Medical Oncologist at St Vincent’s University Hospital and Tallaght Hospital, Dublin, said.
The drug is currently licensed for more advanced patients, who have already received chemotherapy. Its manufacturer, Janssen, is currently in talks with the National Cancer Control Programme on reimbursement for patients, similar to those in the 301 Study.

Shows great promise
Dr McDermott said: “This is an oral agent which shows great promise for patients with advanced prostate cancer, is well tolerated and improves quality of life.”
In addition, an application to the EMA’s Committee for Medicinal Products for Human Use (CHMP) is intended to extend the use of abiraterone acetate administered with prednisone for the treatment of patients with mCRPC who are asymptomatic or mildly symptomatic, after failure of androgen deprivation therapy and before chemotherapy.
Submissions have been made, based on Phase III results, which show “significant improvement” in radiographic progression-free survival and a trend for increased overall survival in patients receiving Zytiga plus prednisone.
The COU-AA-302 trial (the ‘302 Study’) was for patients who had progressed on androgen deprivation therapies but had not yet received chemotherapy.
This study, which included 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy, evaluated the effect of abiraterone acetate plus prednisone on the co-primary endpoints of radiographic progression-free survival (rPFS) and overall survival (OS) compared to placebo plus prednisone. Data from this study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO).

The study was designed with patients in mind who had progressed after standard androgen deprivation therapy. In most parts of the world, this involves either medical (with LHRH agonists) or surgical castration.
Often, an anti-androgen such as bicalutamide is added. When patients progress, further treatment with hormonal agents is often attempted. Some patients who have progressed after androgen deprivation do wish to receive chemotherapy. “Zytiga could prevent patients with known castration–resistant, metastatic prostate cancer  from getting chemotherapy for quite a while,” Dr Bill Hait, Global Head, Janssen Research and Development and Head of the firm’s Oncology Therapeutic Area, proposed.
During an interim analysis, the independent data monitoring committee advised that the study be closed prematurely because of the benefits seen in the Zytiga arm.
“There were remarkable improvements in measurements of clinical benefits, including progression-free survival, time to chemotherapy and opiate use,” said Dr Hait.
In terms of radiographic progression-free survival, in the control arm, the median was 8.3 months. In the Zytiga arm, the median had not yet been reached. There was at least a doubling of freedom from progression. “A 33 per cent improvement has already been observed in median overall survival; in the Zytiga arm, the median still has not been reached. In the control arm, the median was 27 months,” Dr Hait said.
There are a number of other new treatments in the oncology drug development pipeline and the strategy which led to Zytiga has yielded further therapies such as Salvestrols which are also now available in Ireland.