Zytiga Favourable Over Jevtana

The majority of current Zytiga prescribers that are oncologists or urologists are satisfied with Zytiga’s overall clinical performance, but in the docetaxel-treated MCRPC setting Sanofi’s Jevtana (cabazitaxel) poses considerable competition to Zytiga. However, the vast majority of surveyed oncologists and urologists consider Zytiga to be favourable over Jevtana. In various different docetaxel-treated MCRPC patient sub-populations, Zytiga has already captured greatest patient share out of any currently available therapy according to surveyed urologists and oncologists in the USA.

While uptake of Zytiga is significant in the docetaxel-treated MCRPC patient population, physicians also believe use of Zytiga prechemotherapy is appropriate in multiple other prostate cancer patient populations.

NICE Set to Approve Zytiga for use on the NHS

Nice 'to reverse ban on prostate cancer drug'

A proposed ban on a drug that extends the life of prostate cancer patients is set to be reversed in a U-turn by the NHS rationing body.

Tests show men taking abiraterone and a steroid survived for nearly 15 months Photo: ALAMY

10:42AM BST 14 May 2012

Abiraterone, which costs £3,000 for a month's treatment, was at first judged too expensive by the National Insitute for Health and Clinical Excellence (Nice).

But following a campaign by charities - and a rare intervention by the Department of Health - the body is poised to announced later this week that the drug will be approved, it was reported.

It will be the first specific treatment for the disease - that strikes 40,000 British men each year - approved for use on the NHS for more than a decade.

Abiraterone is one of two new drugs which have been shown to prolong survival when other treatments have failed with the other, cabazitaxel, denied to NHS patients in a Nice ruling last week.

Tests show men taking abiraterone and a steroid survived for nearly 15 months, while those given steroid treatment and a 'dummy' pill lived 11 months on average.

 

But some receiving the treatment survived much longer than expected, including Britons who have lived for almost five years with advanced disease.

The pill, which is taken four times a day, also eases pain and improves quality of life.
Nice issued draft guidance in February not to approve the treatment, despite complaints that it had not used the correct criteria to assess it.
But days later Simon Reeve, a Department of Health official, wrote to the body asking that it should "carefully consider" if abiraterone met the more lenient 'end of life' criteria.
This measure, which is supposed to give weight to the value of a few extra months for terminally ill patients, has now been used by Nice leading it to reverse its decision, according to the Daily Mail.
Around 3,300 men with advanced prostate cancer that has become resistant to standard hormone treatments could benefit from abiraterone each year.
The drug, made by Janssen, was developed by UK scientists at the Institute of Cancer Research and trials were partly funded by UK charities.
Owen Sharp of the Prostate Cancer Charity campaign said MPs and patients had been appalled by the initial decision to ban it for NHS use when it was available in other EU countries.
He told the Mail: "It was the wrong decision. This breakthrough drug will make a real difference to men with prostate cancer at the end of their life who have no alternative - this is the only hope they have."

Zytiga Overtakes Provenge as Favourite with Oncologists

Zytiga overtaking Provenge in MCRPC

Despite no current approval of Johnson & Johnson (NYSE: JNJ) subsidiary Janssen’s Zytiga (abiraterone acetate) in asymptomatic/minimally symptomatic metastatic castrate-resistant prostate cancer (MCRPC), 31% of US surveyed physicians report decreased use of Dendreon’s Nasdaq: DNDN) Provenge (sipuleucel-T) because Zytiga is available, according to a new survey of 106 US urologists and medical oncologists from BioTrends Research.

The US Food and Drug Administration-approved indication for Zytiga in docetaxel-treated MCRPC patients means that more surveyed oncologists than urologists have prescribed Zytiga. The majority of medical oncologists have prescribed Zytiga compared with less than a quarter of surveyed urologists. Oncologists typically manage the treatment of symptomatic MCRPC patients at the point at which chemotherapy is initiated, but urologists manage hormonal therapies in earlier lines of prostate cancer treatment.

Surveyed urologists and oncologists agree that urologists now have a greater role in the treatment of MCRPC as a result of the launch of the novel hormonal therapy, Zytiga. However, urologists and oncologists have differing opinions about the future role of urologists in MCRPC treatment.

Zytiga Favourable Over Jevtana

The majority of current Zytiga prescribers are satisfied with Zytiga’s overall clinical performance, but in the docetaxel-treated MCRPC setting Sanofi’s Jevtana (cabazitaxel) poses considerable competition to the growth of Zytiga. However, the majority of surveyed oncologists and urologists consider Zytiga to be favorable over Jevtana. In various different docetaxel-treated MCRPC patient sub-populations, Zytiga has already captured greatest patient share out of any currently available therapy according to surveyed urologists and oncologists in the USA.
While uptake of Zytiga is significant in the docetaxel-treated MCRPC patient population, physicians also believe use of Zytiga is appropriate in multiple other prostate cancer patient populations.

Abiraterone May Soon Be Available On The NHS

Prostate drug ban lifted as NICE U-turn gives cancer sufferers chance of longer life

By Jenny Hope
PUBLISHED: 01:46, 14 May 2012 | UPDATED: 02:15, 14 May 2012

The UK NHS rationing body is poised to reverse a proposed ban on a drug that will give precious months of extra life to men with advanced prostate cancer.
The U-turn is a victory for the Daily Mail, which has fought for years for better care for prostate cancer sufferers, and follows a campaign by the Prostate Cancer Charity and a rare intervention by the Department of Health.
Zytiga (Abiraterone Acetate) – which costs £3,000 for a month’s treatment – was judged too expensive by the National Institute for Health and Clinical Excellence.

Armoury: Drugs like abiraterone and cabazitaxel, which cost around £3,000 for a month's treatment, have been proven to add months to terminally-ill patients' lives

But now the drug will be the first specific treatment for the disease approved for use on the NHS for more than a decade.
Experts say it is stark evidence of the neglect of those who suffer from a disease that strikes 40,000 British men each year.
Zytiga (Abiraterone Acetate) is one of two new drugs proved to prolong survival when other treatments have failed. The other, cabazitaxel, was banned for NHS use last week.
Trials show that men taking abiraterone and a steroid survived for nearly 15 months, while those given steroid treatment and a ‘dummy’ pill lived for 11 months on average.
But some patients live far longer than expected, including Britons who have survived on the drug for almost five years with advanced disease. Abiraterone is widely believed to have kept Lockerbie bomber Abdelbaset Al Megrahi alive.

 

The pill, taken four times a day, also eases pain and improves quality of life.

The plan to ban the drug was adopted by NICE despite protests that it failed to use the correct criteria to assess it.
Cancer specialists said it should have been assessed under the end-of-life system in which NICE is supposed to give weight to the value of a few extra months for terminally ill patients.
The outcry was led by the Prostate Cancer Charity, while Department of Health officials asked NICE to ‘carefully’ reconsider its proposal.
The rationing body is expected to announce this week that it will approve the drug using end-of-life criteria.

Effective: Abiraterone is widely credited with keeping Abdelbaset al-Megrahi alive for much longer than doctors first predicted

It also looked at data from the Cancer Drugs Fund, which gives patients in England access to treatments that are hard to obtain on the NHS, suggesting it is the second most popular drug, after Avastin for bowel cancer.
Around 3,300 British men with advanced prostate cancer that has become resistant to standard hormone treatments could benefit each year from abiraterone.
The drug, manufactured by Janssen, was developed by UK scientists at the Institute of Cancer Research and trials were partly funded by British charities.
Owen Sharp of the Prostate Cancer Charity said its campaign had been supported by patients and MPs appalled at the prospect of a drug available in other EU countries being banned here.
He said: ‘It was the wrong decision. This breakthrough drug will make a real difference to men with prostate cancer at the end of life who have no alternative – this is the only hope they have.
‘It gives them significant extra months of life. It also gives a huge reduction in pain. Disagreement over cost was not a reason to deny it to patients.’
Professor Jonathan Waxman, a prostate cancer specialist at Imperial College London, said the proposal to ban abiraterone was based on false cost estimates and had ignored end-of-life criteria meant to apply to such drugs.
He added: ‘The ban should be reversed because it would limit what we as clinicians can do for our patients and their families.’
NICE’s decision will affect patients in England and Wales. The drug is banned for use on the NHS in Scotland, but the decision will be reviewed.

Zytiga Vs MDV 3100

There has been much hype regarding the new antiandrogen MDV 3100 (Enzalutamide) and its potential rivalry with Zytiga. Here is an analysis of the pros and cons of each agent to give a comparison of their utility in treating prostate cancer.

Zytiga (Abiraterone Acetate)

CYP17 Inhibitor. Designed specifically for prostate cancer targetted at the CYP17 enzyme responsible for testosterone biosynthesis.

Potential Utility: Last line hormonal therapy pre chemotherapy.

Advantages
Oral Drug. Good safety profile.
Licensed for the treatment of advanced prostate cancer post chemotherapy.
Used off label for pre chemotherapy patients.

Disadvantages
Prednisone for side effects.


Enzalutamide (MDV 3100)

Antiandrogen. Designed as an analogue of casodex (bicalutamide) and flutamide.

Potential Utility: Casodex relapsed patients. Combination with Zytiga for advanced prostate cancer.

Advantages
Oral Drug. Prednisone not required.

Disadvantages
Not currently licensed. Presently in Phase 3 clinical trials.
Possible cardiotoxic side effects (5 seizures reported in trials)

Zytiga Shows Clear Survival Advantage

Zytiga shows clear survival advantage in prostate cancer patients (upper plot) when compared to placebo (lower plot).

Abiraterone was Designed to be Absorbed with Food

Abiraterone Acetate (Zytiga) is a new drug for treating advanced prostate cancer. It has been specially formulated as the acetate derivative so that it can be easily absorbed with food. It is important to realise that when given with food a much lower dose of Zytiga is needed. Giving Zytiga at a dose of 4 tablets daily on an empty stomach makes no sense either scientifically or economically. This dose was primarily used for pharmacological studies in clinical trials. Because these are the conditions upon which the clinical results were obtained the recommendation to take 4 tablets on an empty stomach has remained. The truth is that only 5% of Abiraterone Acetate is absorbed on an empty stomach, and 95 % of the drug is excreted. A much higher absorption can be obtained by taking Zytiga shortly after eating. In this way the drug absorption increases 5 fold, so that a single 250 mg tablet has the effect of over 4 tablets on its own. Taking 1 tablet after eating breakfast is a much more sensible approach and is much easier to adhere to. This aspect is currently being tested in clinical trials and it is clear that 1 tablet taken with food is a safe dose to take.