Is Zytiga Legislation Encouraging Docetaxel Treatment ?

Zytiga is currently approved for use in the post chemotherapy setting and the label stipulation is that patients must have received at least one course of docetaxel based chemotherapy. Use of Zytiga pre chemotherapy is considered an off-label use of this drug and the drug is currently not approved in this setting. Insurance company reimbursement of drug costs will only be made for use of the drug according to the label, and that means post chemotherapy. Furthermore the approved prescription usage of Zytiga in some countries requires prior docetaxel treatment.

This raises the possibility that physicians will administer docetaxel so that the patient qualifies for Zytiga treatment. Low dose docetaxel has already been used in this context and perhaps the restrictive legislation on Zytiga usage is actually encouraging the use of docetaxel chemotherapy to qualify for the post chemotherapy criterion.

Approval of Zytiga by the FDA for use pre chemotherapy will resolve this ridiculous situation by allowing the drug to be used on label at an earlier stage without the need for chemotherapy. In the pre chemotherapy setting Zytiga has been shown to delay the need for chemotherapy by over 2 years. The current situation encourages the use of chemotherapy whereas Zytiga was designed to replace the need for chemotherapy.

Zytiga Approved for use in Australia

A drug which extends the life of men with advanced prostate cancer has been approved for use in Australia.
The drug Abiraterone Acetate (Zytiga) is the first of a new generation of drugs to be approved by the Therapeutic Goods Administration (TGA) for men who have become resistant to prostate cancer hormone treatments. This drug was approved in April 2011 in the USA and May 2011 in Europe, but has taken over an extra year before it has finally been approved in Australia.

Professor of medical oncology at the University of Western Sydney Paul De Souza said for the past five years chemotherapy had been the only option for many men with this type of advanced prostate cancer, apart from those in clinical trials.
He said there had been intense drug trials for the past three to four years testing the new treatments.
"This drug, Zytiga, is the first cab off the rank," Prof De Souza told AAP.
"It’s a pill, it’s extremely well tolerated and it prolongs survival.
"it works and it doesn’t cause the side effects that chemotherapy does."
He said two separate trials had shown the drug prolongs survival in men who have failed hormone treatment and chemotherapy but it also worked in men before starting chemotherapy.
Prostate Cancer Foundation of Australia chief executive Dr Anthony Lowe said the drug’s potential to extend the life of sufferers was a significant breakthrough.
"This is a group of men for whom, until 12 months ago, there was really nothing available to them. This is a very important development," he told AAP.
Zytiga works by targeting prostate cancer cell growth by stopping male hormone production at all sources – the testes, adrenal glands and the tumour itself.
University of Queensland Associate Professor of Medicine Dr Paul Mainwaring said prostate cancer growth was fuelled by androgens naturally produced in men.
"By inhibiting androgen production at all sources this new therapy removes the fuel from the fire, reducing the cancer’s ability to grow or spread," Dr Mainwaring said.

The drug’s manufacturer Janssen is working with the federal government to add the therapy to the Pharmaceutical Benefits Scheme (PBS) to be subsidised in Australia.

NICE Confirms Approval of Abiraterone for use on the NHS

NICE the natinonal institute for clinical excellence which is the UK's government drug rationing body has issued its final draft guidance recommending Abiraterone (Zytiga) for use on the natinonal health service NHS of England and Wales to treat advanced prostate cancer.

o        Abiraterone for castration-resistant metastatic prostate cancer previously treated with a docetaxel-containing regimen

NICE Technology appraisals, TA259 - Issued: June 26 2012

NICE recommends abiraterone as a possible treatment for some adults with metastatic prostate cancer who have already had treatment to reduce testosterone and have had docetaxel chemotherapy (see below).

Who can have abiraterone?

You should be able to have abiraterone if you’ve had docetaxel chemotherapy but your disease has stopped responding to treatment.

Why has NICE said this?

NICE looks at how well treatments work, and also at how well they work in relation to how much they cost the NHS. NICE applies special considerations to treatments that can extend the lives of people who are nearing the end of their life. NICE recommended abiraterone because it works better than other treatments available on the NHS. Although it also costs more than other treatments, this was justified by the benefits it provided when the special considerations were applied.

Zytiga Still Working After 6 Years

A drug pioneered by scientists in the UK allows prostate cancer patients to live longer and enjoy a better quality of life.

The oral drug, abiraterone, was designed by Professor Gerry Potter at the Institute of Cancer Research and has been developed through clinical trials by Professor Johann de Bono at the Royal Marsden Hospital in London.

It has been proven to drastically decrease pain and improve the personal well-being of prostate cancer patients.

“Prostate cancer is a pretty horrible cancer, a dehumanising disease, and this pill improves the quality of life and survival rate,” said Prof. de Bono, an honorary consultant in medical oncology at The Royal Marsden Hospital.

The drug gives hope to prostate cancer patients at the late stages of the disease when chemotherapy, surgery or other drugs would have failed. It decreases the incidence of death by about a third but, according to Prof. de Bono, it is “not just about extending survival but also about improving the quality of life”.

Officially, abiraterone can extend survival by about five months but some men live considerably longer.

“Averages are hard to quantify,” he said. “I have a patient who had been living on morphine because of the pain but when he started taking abiraterone he came off the morphine and, six and a half years later, he’s still alive and not in pain,” Prof. de Bono said.

Soon, patients will be able to take the drug even prior to chemotherapy. “Our goal is to make chemotherapy a thing of the past,” he said.

It is deemed the most common cancer in men worldwide and the second most common killer among men after lung cancer.

Patients on abiraterone – which only has minimal side effects – would need to take four pills a day.

Abiraterone is also being tested on patients with advanced breast cancer. The indications are that even children with rare inherited diseases will eventually benefit from the drug.

So is this a miracle cure?

“Please don’t hype it up. We all have to die one day,” said Prof. De Bono. “It doesn’t cure but it does improve the quality of life.”

His “primary goal” in life is to accelerate the process of drugs to move from experimental stage to treatment, which, at the moment, takes approximately 10 years.

“This is a time of great change for cancer medicine because genomic technology allows us to decipher exactly what’s driving each cancer,” he said, explaining that precision medicine allowed researchers to develop specific drugs to target the area that is being hijacked by cancer.

“It’s a question of giving the right patient the right treatment at the right time,” he said.

Because these drugs are expensive, the key challenge is funding and the medical world is trying to minimise cost failures and accelerate success. “How are we, as a society, going to afford such drugs, particularly in these stringent times?”

Prof. de Bono describes cancer as a “complicated beast” but his goal is to eventually “find a drug which cures”.

He spends half his time in the lab and half with patients, which takes its toll on him: “I am ageing very rapidly,” he joked but it is clear that he is driven by passion for his job.

He recounted that only the other day he had received an e-mail from a woman in Australia, whom he had never met. She wanted to thank him because her father had been bedridden with prostate cancer but was now even swimming.

“These true stories keep you going,” he said.

Doctors to Increase Use of Zytiga

A market research company, today released the results of its ASCO Impact Report, a survey of physicians attending the 2012 annual meeting of the American Society of Clinical Oncologists (ASCO). The survey was designed to evaluate the relevancy and effectiveness of company-sponsored clinical data and promotions at ASCO.
Encuity's survey results revealed that this year's event had a significant impact on the treatment plans of oncologists and hematologists in attendance—with 76% indicating that they are likely to change their patient treatment plans based on ASCO findings.
New breast cancer and prostate cancer treatment plans gained the most traction. Among the ASCO-attending physicians surveyed, 45% intend to change their breast cancer treatment plan once Genentech's T-DM1 becomes available, while 44% intend to increase their use of Johnson & Johnson's prostate cancer treatment, Zytiga®.
The majority, 86%, of ASCO-attending physicians also awarded the highest overall "presentation of information" rankings to T-DM1. This endorsement was closely followed by Zytiga®, earning "very or extremely valuable" ratings from 73% of physicians surveyed.
"It is clear that several companies delivered clinical presentation home runs at ASCO, while others did not," said Michael Turner, General Manager of Encuity Research.  "The study also showed that ASCO will have a significant impact on the future behavior of physicians in attendance.
The ASCO Impact Report provides an encompassing view of ASCO attendees' intent to change treatment plans, their perception of clinical information presented, and their ratings of information offered by pharmaceutical and biotech companies.
This report is based on an online survey of 100 oncologists and hematologists who attended the event.

Zytiga Approved in Singapore

Zytiga has been approved by the Health Sciences Authority of Singapore for use in treating advanced prostate cancer.

SINGAPORE: A new drug to treat advanced stage prostate cancer may prolong lives and mitigate pain for patients whose conditions have worsened while on, or after chemotherapy.

Called Zytiga, the pill has been approved by the Health Sciences Authority of Singapore.

Prostate cancer is the third most common cancer among Singaporean men.

In global clinical trials, patients lived an average of 4.6 months longer after taking the drug.

The pill suppresses the body's production of testosterone, the male sex hormone, which has been linked to the growth of prostate cancer.

Drug manufacturer Janssen said it is priced competitively with other comparable treatments in the market.

The National Cancer Centre Singapore said local patients have taken well to the drug.

Doctors said side effects such as fluid retention and low potassium levels are manageable when taken with prednisone.

 

Zytiga Still Working After 3 Years

Michael Wells, 65, a retired construction worker from Oakville in California's Napa Valley, was diagnosed nearly 12 years ago with prostate cancer that had spread to his bones. Standard hormone and radiation treatments kept it in check for many years, but when it started growing, he enrolled in the clinical trial study of Zytiga.

Zytiga gave him high blood pressure but other than that, "I have not noticed any difference taking the pills -- I've always had hot flashes" on prostate medicines, he said.

He has now been on Zytiga for three years now, and scans show his cancer is in check.

"It's worked for me, and it's still working," Wells said.