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Yogi Amin
Paul Bould's solicitor |
Speaking from his hospital bed at the Lancaster Royal Infirmary, Mr Bould said the drug could prolong his life.
He said: "I'm over the moon about this decision. I've been on the drug for the last two months after my doctor prescribed it.
"It has stopped my coughing and made it easier for me to breathe."
Mr Bould's solicitor, Yogi Amin of law firm Irwin Mitchell, who represented breast cancer sufferer Ann-Marie Rogers in her battle for the drug Herceptin, said his client's case was "particularly desperate".
He added: "We have evidence that this drug would significantly improve his quality of life as well as help extend it.
'Symptoms improved'
"When he took the drug, Paul's condition improved measurably almost immediately.
"His tumour stopped growing and his symptoms improved considerably.
"He could now be entering the final phase of his life and to deny him this drug on financial grounds is wrong on every level.
"However, in particular we will be arguing that denial of this drug is a breach of Paul's human rights and in particular his right for life."
The injunction means that Mr Bould, who was diagnosed in August 2004, will continue to receive the drug until a full judicial review can be heard.
Morecambe Bay PCT
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A statement from Morecambe Bay PCT said: "The PCT is committed to funding medical treatment, support and care of proven effectiveness for patients with all forms of cancer.
"However, the PCT faces major challenges in fulfilling its responsibility to all its residents in Morecambe Bay to make best use of finite available funds, to prioritise funding for those drugs and medical treatments that are cost effective and of proven medical effectiveness."
Funding for Tarceva has not been approved by any of the cancer networks
in the north-west of England, it added.
Smart drug for lung cancer tested Last Updated: Monday, 29 November, 2004, 15:33 GMT |
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Researchers at more than 70 UK centres will test the drug, Tarceva, as a treatment for advanced lung cancer. The drug, taken as a simple white pill, targets a molecule which plays a key role in the growth and extended lifespan of cancer cells. The trial is being coordinated by the Cancer Research UK and University College London.
Not only is the trial designed to evaluate the effectiveness of the drug, experts also hope it will provide information on which patients will benefit the most. The drug cannot cure people with advanced lung cancer - but it is hoped it will boost their life expectancy. Doctors will aim to recruit 664 patients with advanced non-small cell lung cancer, which accounts for three quarters of cases of the disease. Lead researcher Dr Siow Ming Lee said: "Conventional chemotherapy is of limited use against advanced lung cancer. "Tumour cells quickly become resistant to treatment, while chemotherapy doesn't properly distinguish between cancerous cells and healthy ones and has too many side effects for many very ill lung cancer patients to cope with." Subtle approach Dr Lee said the new approach was rather more subtle. It involves targeting a molecule which is more important for cancer cells than for their healthy counterparts. The molecule - epidermal growth factor receptor (EGFR) - relays instructions to cells to grow and divide, and to ignore signals telling them to die. It seems to be particularly important for the growth and survival of some cancer cells and large amounts of the molecule are often present in the cells of non-small cell lung cancers, sometimes in a mutated, over-active form. After treatment, researchers will analyse patients' tumour and blood samples, to determine whether the type or amount of EGFR affects the way a patient responds to treatment. This could pave the way for a test to predict which patients are most likely to benefit from the drug. Tarceva has already produced promising results in a trial on patients with non-small cell lung cancer who had already been heavily treated with chemotherapy. The new trial will assess the benefits of the drug as a first line treatment on patients considered unsuitable for standard chemotherapy. Dr Lee said: "Tarceva has minimal side effects and patients should be able to cope with it much better than they would with conventional chemotherapy." Professor Robert Souhami, of Cancer Research UK, said: "We are seeing important changes in our approach to the treatment of some cancers, with researchers beginning to test out more specific anti-cancer therapies in place of broad-action chemotherapy. " "The new trial will test out one such selective anti-cancer agent, which we hope will make some headway against a disease which is notoriously difficult to treat. "By providing a treatment which patients can take at home in simple pill form, it may also make a significant contribution to improving the quality of life of very ill cancer patients." Tarceva decisionTHURSDAY 16 NOVEMBER 2006Cancer Research UK has expressed its disappointment at the preliminary decision of medical regulator Nice to not make lung-cancer drug Tarceva available on the NHS.While not a cure, the drug is one of the only significant advances in the past decade against 'non-small cell' lung cancer ? an aggressive and hard-to-treat form of the disease . Alex Markham, chief executive of Cancer Research UK, said that Tarceva had been shown to significantly extend the lives of non-small cell lung cancer patients. "The results of ongoing clinical trials using Tarceva - funded by Cancer Research UK and others - are expected to reveal further important comparative information about the likely benefits of the drug," said Professor Markham. "In the meantime we believe the drug should continue to be made available to those who could benefit from it. "Tarceva is used as a standard treatment in many other European countries. It is also available to certain patients in Scotland and it would be incomprehensible for such a drug to be available to patients in Edinburgh but not Newcastle." Professor Markham added that Cancer Research UK would write to Nice expressing its opposition and calling for a reappraisal of its decision.
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Basel, 26 April 2004
New cancer drug Tarceva - a breakthrough with significant survival
benefit in patients with advanced lung cancer
First and only drug in a new class (HER1/EGFR-inhibitors) to show survival
benefit in a randomized phase III trial
Roche, Genentech, Inc. and OSI Pharmaceuticals, Inc., today announced positive results from a phase III study of Tarceva (erlotinib) in relapsed non-small cell lung cancer (NSCLC) patients. The study met its primary endpoint of improving overall survival with patients on Tarceva living longer than those in the placebo arm. The trial also met secondary endpoints including improving time to symptomatic deterioration, progression-free survival and response rate.
“These Tarceva results are great news, confirming the earlier promising single agent activity in patients with relapsed non-small cell lung cancer. Tarceva is the first and only EGFR-targeted drug showing improved survival in patients with NSCLC. We will be striving to make Tarceva available as quickly as possible to patients,” said William M. Burns, Head of Roche’s Pharmaceuticals Division. “Tarceva joins Herceptin, MabThera, Xeloda and Avastin as the fifth cancer medicine in our portfolio with a proven survival benefit. This puts us in an unparalleled position and further underlines Roche’s leadership in oncology.”
“Tarceva is the first EGFR-inhibitor that has been shown to extend survival in patients with relapsed non-small cell lung cancer, for whom there are very limited treatments possible,” said Professor Nick Thatcher, Chairman on Lung Cancer Group, Christie and Wythenshawe Hospitals Manchester, UK. “The results of this controlled trial with Tarceva are very exciting for all of us in the oncology community. But even more so for people with lung cancer, the biggest cancer killer in Europe.”
About the Study
The international study was conducted by the National Cancer
Institute of Canada, Clinical Trials Group at Queens University (NCIC
CTG) in collaboration with OSI. The primary endpoint in this study was
overall survival. Secondary endpoints include time to symptomatic deterioration,
progression-free survival, safety, and tumour response.
The alliance of Roche, OSI and Genentech will work with the NCIC CTG to submit data from this phase III trial for presentation at the upcoming 2004 Annual Meeting of the American Society of Clinical Oncology (ASCO) in New Orleans from June 5 8.
About Tarceva
Tarceva is a small molecule designed to target the human epidermal
growth factor receptor 1 (HER1) pathway, which is one of the factors
critical to cell growth in many cancers. HER1, also known as EGFR, is
a key component of the HER signalling pathway, which plays a role in
the formation and growth of numerous cancers. Tarceva is designed to
inhibit the tyrosine kinase activity of the HER1 signalling pathway
inside the cell, which may block tumour cell growth. Results of a phase
III trial of Tarceva in pancreatic cancer are expected in the second
half of 2004. Early-stage trials of Tarceva are being conducted in other
solid tumours, such as ovarian, colorectal, head and neck, renal cell
carcinoma, glioma and gastrointestinal cancers.
About Non-Small Cell Lung Cancer
According to the World Health Organization, there are more
than 1.2 million cases worldwide of lung and bronchial cancer each year,
causing approximately 1.1 million deaths annually. Non-small cell lung
cancer is the most common form of the disease and accounts for almost
80 percent of all lung cancer.
Roche in Oncology
Within the last five years the Roche Group has become the world’s
leading provider of anti-cancer treatments, supportive care products
and diagnostics. Its oncology business includes an unprecedented four
marketed products with survival benefit: Herceptin, MabThera, Xeloda
and Avastin which has been launched in the US recently, treat a range
of malignancies such as breast cancer, non-Hodgkin’s lymphoma
and colorectal cancer. Other key products include NeoRecormon (anaemia
in various cancer settings), Bondronat (prevention of skeletal events
in breast cancer and bone metastases patients, hypercalcemia of malignancy),
Kytril (chemotherapy and radiotherapy-induced nausea and vomiting) and
Roferon-A (leukaemia, Kaposi's sarcoma, malignant melanoma, renal cell
carcinoma). Roche’s cancer medicines generated sales of more than
6 billion Swiss francs in 2003.
Roche is developing new tests which will have a significant impact on disease management for cancer patients in the future. With a broad portfolio of tumour markers for prostate, colorectal, liver, ovarian, breast, stomach, pancreas and lung cancer, as well as a range of molecular oncology tests, we will continue to be the leaders in providing cancer focused treatments and diagnostics.
Roche Oncology has four research sites (two in the US, Germany and Japan) and four Headquarter Development sites (two in the US, UK and Switzerland).
About the Companies
Headquartered in Basel, Switzerland, Roche is one of the world’s
leading innovation-driven healthcare groups. Its core businesses are
pharmaceuticals and diagnostics. Roche is number one in the global diagnostics
market, the leading supplier of pharmaceuticals for cancer and a leader
in virology and transplantation. As a supplier of products and services
for the prevention, diagnosis and treatment of disease, the Group contributes
on a broad range of fronts to improving people’s health and quality
of life. Roche employs roughly 65,000 people in 150 countries. The Group
has alliances and R&D agreements with numerous partners, including
majority ownership interests in Genentech and Chugai.
Genentech is a leading biotechnology company that discovers, develops, manufactures and commercialises biotherapeutics for significant unmet medical needs. Eighteen of the currently approved biotechnology products originated from, or are based on, Genentech science. Genentech manufactures and commercialises 13 biotechnology products in the United States. The company has headquarters in South San Francisco, California, and is traded on the New York Stock Exchange under the symbol DNA.
OSI Pharmaceuticals is a leading biotechnology company focused on the discovery, development, and commercialisation of high-quality, next-generation oncology products that both extend life and improve the quality of life for cancer patients worldwide. OSI has a balanced pipeline of oncology drug candidates that includes both novel mechanism-based, gene-targeted therapies focused in the areas of signal transduction and apoptosis and next-generation cytotoxic chemotherapy agents. OSI has a commercial presence in the U.S. oncology market where it exclusively markets Novantrone (mitoxantrone concentrate for injection) for approved oncology indications and Gelclair for the relief of pain associated with oral mucositis.
Drug improves survival in lung cancer patients
Scientists are hailing the news about Tarceva, announced at a meeting of the American Society of Clinical Oncology in New Orleans, as an important advance in cancer therapy.
Tarceva did not cure anyone.
But in an international clinical trial of more than 700 patients, scientists found that those who took Tarceva survived an average of 6.7 months, while those who received a placebo lived 4.7 months, according to the study, presented by Frances A. Shepherd, a professor of medicine at the University of Toronto. Patients were randomly assigned to receive either Tarceva or a sugar pill, and neither patients nor their doctors knew who was getting the real drug.
Patients in the study had cancers that were advancing in spite of being treated with one or two rounds of chemotherapy. The outlook for these patients was grave, Shepherd said at a press conference.
At the end of one year, however, about 30% of those taking Tarceva were still alive, compared to about 20% of those receiving no treatment.
For patients at this stage of the disease, with little hope from conventional chemotherapy, those are impressive results, said Shepherd, whose trial was led by the National Cancer Institute of Canada Clinical Trials Group and included doctors from several countries.
Drugs that prolong survival in patients this sick are relatively rare, said Roy Herbst, chief of thoracic medical oncology at the M.D. Anderson Cancer Center in Houston, who has used Tarceva in studies. More often, new drugs are found to be about as good as the old ones, with somewhat fewer side effects.
"This is just tremendous," said Herbst, who has worked with Tarceva — which has not yet been approved — in studies.
Tarceva also gave patients better quality of life, Shepherd said. Their symptoms — cough, pain and shortness of breath — deteriorated more slowly than those who did not get the drug, she said.
"Not only did our patients live longer, but I like to say that they lived better," Shepherd said. "They now have an option that will prolong their lives, improve their symptoms and do it with very little toxicity."
Tarceva, like other new therapies that target specific enzymes within tumor cells, causes fewer serious side effects than traditional chemotherapy, which uses toxic doses to kill growing cells and often causes hair loss, nausea, fatigue and mouth sores. Tarceva — a pill taken once a day — is easier to administer than most chemotherapy, which is typically given in intravenous infusions that can take hours.
In this trial, Tarceva's major side effects were a rash and diarrhea, according to the study. About 12% of patients developed a rash severe enough to reduce their dose of medicine. About 5% of patients taking Tarceva stopped taking it because of side effects, compared to 2% of patients taking placebos
An innovative cancer drug has been turned down for use on the NHS, shortening the lives of thousands of people who could benefit from it. Erlotinib trades under the name Tarceva and is used to treat lung cancer. It joins a growing list of banned treatments that have failed to convince the NHS rationing organisation. Yesterday the National Institute for Health and Clinical Excellence (Nice) said it was not recommending erlotinib – which is available for certain patients in Scotland - for people whose lung cancer has spread. The drug is designed to treat non-small cell lung cancer, the commonest form of the disease, for which there is little treatment. There are 37,100 new cases of lung cancer in Britain each year and 33,000 deaths. Non-small cell lung cancer accounts for 80 per cent of the total. The drug, taken as a pill, costs £1,600 a month or £6,800 for a typical course of treatment and is already being used in some parts of the country. Like several others on the banned list, it does not claim to cure but can prolong life and relieve symptoms. It can also extend life by a year. Prof Alex Markham, chief executive of Cancer Research UK, which is funding research into the drug, said: "It is deeply disappointing to know that if these current recommendations stand, Tarceva will not be available to patients in England. "Nice reports a lack of direct evidence about the benefits of Tarceva compared with the drug docetaxel, but lack of evidence does not mean evidence of a lack of benefit. "Non-small cell lung cancer is very difficult to treat, and Tarceva is one of the few significant advances against the condition to emerge over the last decade. While not a cure, the drug can significantly extend the lives of patients with this form of lung cancer." It is used as a standard treatment in many other European countries. |
24/08/2006
Lawyers for Linda Gordon (47) who is dying of lung cancer have today issued proceedings to take her Primary Care Trust (PCT) to the High Court in a bid for her to get the cancer drug, Tarceva, which her doctor has prescribed for her.
Ms Gordon, who has two daughters Charlie (28) and Jody (20), has been forced to fund an initial dose of this drug herself as she has been refused funding by Bromley PCT. A life-long non-smoker, Ms Gordon was described by her consultant oncologist, Dr Prendiville, as 'absolutely the ideal patient to be treated with this agent [Tarceva or Erlotinib]'
An independent report by Dr Jeremy Steele a consultant thoracic oncologist has confirmed that Ms Gordon is the ideal patient for the drug which could extend her life for up to 18 months.
Dr Steele states in the report that a number of factors including being female, young, fit and a non-smoker place Ms Gordon in a small minority of lung cancer patients who are likely to benefit most strongly from the treatment. Large-scale clinical trials and case studies have shown that for those who respond well to the treatment it can have outstanding results in terms of fighting the progression of the disease and significantly reducing the pain and other symptoms suffered by patients in the advanced stages of lung cancer.
Ms Gordon says that already the few weeks of the tablets that she has been able to afford have made an incredible difference to her symptoms and given her a new lease of life. She believes that this shows the treatment is acting to shrink the tumours, as has been the case for other patients treated with the drug.
The law firm Irwin Mitchell who represents Ms Gordon and which also successfully fought for Ann Marie Rogers to receive the drug Herceptin, has highlighted the fact that it is not only the provision of the drug that varies dependent on where you live in the UK, but also the price charged by the PCT for those forced to fund it themselves.
One of the other patients fighting for Tarceva, who sadly died last month having just won the right to receive the drug, Paul Bould, was charged only £1500 for a month's treatment. Mrs Gordon has managed to pay for the drug, for a month, at a cost of £2100.
However this cost was achieved after much negotiation as Ms Gordon had to 'haggle' the price down from the original quoted amount of £3400. Ms Gordon is now unable to pay for any more of the tablets and is therefore taking her fight to the High Court to force the PCT to continue to pay for the treatment her consultant has recommended.
The Irwin Mitchell lawyer representing Ms Gordon, Kate Fletcher, said: "It would seem that the cost of this drug is arbitrary, and varies depending on where you live and your ability to negotiate. We would ask both the Department of Health and the drug firms to justify the costs of these drugs and how their pricing mechanism works."
Ms Fletcher added "To prevent Ms Gordon having to fund any more treatments, and ensure she gets the drug her doctor has prescribed for her, we are now issuing proceedings against the decision by the PCT to deny Linda this drug. We will be starting a judicial review against this decision and hope that doctors are recognised as being the best people to treat patients"
A TERMINAL cancer sufferer has won the first round in her fight to get funding for life-prolonging drugs.
Linda Gordon was told she may have only nine months to live when she was diagnosed with lung cancer 15 months ago.
Despite having been declared an "excellent" candidate for the tumour-shrinking drug Tarceva, by her doctor, Mrs Gordon was refused funding for it by Bromley Primary Care Trust (PCT).
The mother-of-two took her battle to the High Court and was told the grounds for Bromley PCT's refusal of the drug were "flawed".
Mrs Gordon's solicitors at law firm Irwin Mitchell launched proceedings to appeal for a judicial review of the PCT's refusal to fund a month of treatment.
Prior to the September 1 hearing, Bromley PCT agreed to the request.
The former pharmaceuticals worker said: "My solicitor tells me it is a victory at this stage."
Bromley Primary Care Trust (PCT) initially refused her application for the tablets, citing "finite resources" and "limited evidence of effectiveness".
Depending on her response to the drug, Mrs Gordon, of Southborough Lane, Bromley, will reapply for further courses of the drug.
If the PCT refuses once more, the matter could return to court.
Mrs Gordon said: "I am not giving in to anything, I'm taking this all the way."
An Irwin Mitchell spokesman said: "Effectively the PCT folded by agreeing to the treatment. They agreed to what we asked for so there as no need for the review."
Mrs Gordon was represented by Yogi Amin, who won an appeal allowing breast cancer sufferer Ann Marie Rogers to be treated with the drug Herceptin.
Mr Amin said: "The judge determined there was an arguable case that Bromley PCT's decision to refuse funding was flawed.
"On hearing this, Bromley PCT decided they would fund the next month. We will see how Mrs Gordon's cancer progresses and if we need it for longer than that we will go back to the PCT.
"If they refuse us at a later stage, Mrs Gordon will have no hesitation to take the matter to the High Court.
"It is a victory - the judge argued there were sufficient grounds for a judicial review. We have won this stage of the battle."
A Bromley PCT spokesman said: "We don't agree with the interpretation put on this case by Ms Gordon's solicitors. Their application for a judicial review was refused.
"The High Court has considered the PCT's decision not to fund Tarceva for Ms Gordon and dismissed the claimant's application for judicial review.
"If a fresh request for Tarceva is made by Ms Gordon to fund an individual clinical trial, the PCT has been asked to consider this expressly.
"In the context of the litigation, the PCT has agreed to fund Tarceva for Ms Gordon between August and September 2006."
5:10am Tuesday 5th September 2006
By Sara Nelson
THOUSANDS of lung cancer patients in Scotland are to be given access to the world's first once-a-day pill to treat the disease, after many were denied it on the NHS.
The Scottish Medicines Consortium (SMC) yesterday approved the drug Tarceva for use by patients with an advanced form of the most common type of lung cancer.
This means health boards will be obliged to fund the drug - which costs £1,700 a month per patient - in patients whose doctors think they will benefit from the treatment.
Campaigners said many patients had been denied the drug by health boards in Scotland and were told the money was not there to pay for it.
The Roy Castle Lung Cancer Foundation said it had received calls from patients and their families desperate to get the drug, which can increase life expectancy by months. But many do not live long enough to see through their appeals and challenges to health boards.
Dr Marianne Nicolson, a leading lung cancer specialist at Aberdeen Royal Infirmary, said the SMC's decision to recommend Tarceva was "fantastic news" for doctors and patients. She said Scottish patients were the first in the UK to benefit from the drug, which is unlikely to be reviewed by the National Institute for Health and Clinical Excellence for use in England and Wales before 2007.
"This drug is not a cure, but it makes a massive difference to a patient's quality of life," she said. "They are likely to feel less breathless, have less of a cough and less pain.
Dr Nicolson said that the drug could also give patients valuable extra months with their families. In some cases, where patients responded well to the treatment, they could live for years rather than months.
And as the drug is in pill form, it can be taken in the comfort of patients' homes rather than them having to spend hours in hospital on a drip.
About 4,500 people are diagnosed with lung cancer in Scotland every year, with rates of the disease much higher than elsewhere in the UK.
Tarceva has been recommended for use in patients with advanced non-small cell lung cancer who have failed to respond to one other chemotherapy treatment.
This could make the drug suitable for more than 1,500 patients every year.
Drug trials show that 31 per cent of patients taking Tarceva were still alive a year after treatment, compared with 20 per cent of those on a placebo.
Tarcevea also reduced the risk of the disease progressing by 39 per cent.
Currently, half of lung cancer patients are not offered active treatment for their illness because the options available are not considered to be appropriate or the person was not fit enough to receive it.
Dr Nicolson said the cost of the Tarceva was high, but the effect on patients' quality of life and the benefits of being able to spend longer with their families were immeasurable.
Susan Christie, of the Roy Castle Lung Cancer Foundation, said the SMC decision should mean that patients are no longer denied access to Tarceva on the NHS.
"A lot of patients have been told by their doctors that there is this drug that could help them, but the health boards say they cannot pay for it," she said.
"A lot of patients have appealed against the decision, have written to their MSP and considered what legal action they could take.
"But by the time they have gone through this process it is often too late."
Amjad Hussain, 37, of East Kilbride who has lung cancer, has been taken Tarceva for seven months. He said the drug had made a massive difference to his life, allowing him to spend more time with his wife, Angela, and their children Nadia, three and Haylie, nine.
"After I had been taking the drug for a few months I had a scan and it showed that the tumour had shrunk," Mr Hussain said.
"It has been really good and I am glad I have been allowed to take it."
Mr Hussain said it was a massive shock when he was diagnosed with lung cancer in November 2002.
"I have never smoked, I played football, I went to the gym and I was fine.
"I ran a hot food takeaway, so I was not exposed to smoking or anything."