Showing posts with label Kidney Cancer. Show all posts
Showing posts with label Kidney Cancer. Show all posts

Sutent for kidney cancer approved on NHS but other drugs turned down

The National Institute for Health and Clinical Excellence (Nice) had previously said that all four kidney cancer drugs would not be made available on the health service because they were too expensive and did not extend life beyond a few months in most cases.

There was a public outcry and patients said they were being condemned to an early death.

The drugs were looked at again under new rules allowing more expensive drugs for terminal patients to be approved, but three out of the four drugs were still not cost effective, Nice has announced.

Sutent, also known as sunitinib was approved, but Avastin, also known as bevacizumab; Nexavar, also known as sorafenib; and Torisel, also known as temsirolimus, were turned down.

Charities have said the ruling is disappointing as it means patients who do not respond to Sutent, also known as sunitinib, do not have any other drugs to try.

Roche, makers of Avastin, condemned the decision, saying the drug was turned down simply because it is licensed to treat other cases, in this case breast cancer, bowel cancer and some lung cancers.

John Melville, General Manager of Roche UK, said: “This decision is entirely illogical and neither addresses the needs of patients with renal cancer, nor advances the innovation agenda. Avastin demonstrates the same value to the NHS as sunitinib and this guidance goes against the spirit of end of life criteria which were devised for this very setting.”

The rules which allow Nice to pass more expensive drugs if they are for small patient populations at the end of life do not apply if the drug is already licensed for other conditions.

Dr Vignesh Rajah, Medical Director of Wyeth said: “It further accentuates the disparity in cancer care between the UK and other advanced countries, where Torisel and other innovative renal cell cancer drugs are routinely used. NICE’s rejection also conflicts with professional treatment guidelines on renal cell cancer published earlier this year, recommending Torisel as first line treatment for poor prognosis patients.”

Roche and Bayer, makers of Nexavar, which is also used for some forms of liver cancer, had agreed schemes with the Department of Health to provide some of the treatment free but were still turned down.

Pfizer, makers of Sutent, also provide the first cycle of treatment to NHS patients for free.

The average daily cost of Sutent per patient is £74.74, with an average six week cycle costing around £3,139.

Around 7,000 patients a year are diagnosed with kidney cancer in Britain and around 3,600 will be eligible for treatment with Sutent because their disease is advanced enough.

The drug has been shown to increase survival by several months, and in some cases for up to two years, but does not cure the disease.

Professor Peter Littlejohns, Clinical and Public Health Director at Nice, said: “We are very aware that renal cancer is a devastating disease for the individual and their family.

"We recommended the use of sunitinib for first line renal cancer in March 2009, so one of these new treatments is now available.

"The evidence to support the use of the other first and second line treatments isn’t strong enough to justify using NHS funds, which could be used for other cancer treatment programmes or in other treatment areas.

"Our advisory committee used the additional flexibility we have recently given them to give special weight to drugs that extend life, at the end of life, but the benefit was still too small set against their cost.”

The appeal against the Final Appraisal Determination from Roche, Wyeth Pharmaceuticals, James Whale Fund for Kidney Cancer and a joint appeal from Roarers Cancer Forum and Macmillan Cancer Support, have not been upheld.

Duleep Allirajah, Policy Manager at Macmillan Cancer Support, said: “We are extremely disappointed by NICE’s decision not to make these drugs available to all kidney cancer patients on the NHS.

“These innovative drugs are proven to significantly improve patients’ quality of life and so it is hugely frustrating that despite this, NICE is not allowing patients to access them.

“Ruling out Avastin, Nexavar and Torisel will also mean patients unsuitable for Sutent are left with very few treatment options.

“The fact that kidney cancer patients in Wales can access these drugs highlights the inequalities that exist between nations.”

:: Other guidance was also issued on Erbitux for bowel cancer that has spread.

Nice approved Erbitux, also known as cetuximab, for use in certain circumstances, including that the primary tumour in the bowel must be potentially operable, the cancer must only have spread to the liver and the patient is well enough to go through surgery on the primary tumour and on the liver tumour.

The manufacturer must also rebate 16 per cent of the cost of the drug used on each patient and each case should not be treated with the drug for more than 16 weeks.

The decision was welcomed by patient groups who said it should herald a new era in the treatment of the disease.

A new drug was also approved for the treatment of severe and chronic eczema on the hand that has not responded to steroid drugs.

Toctino, also called alitretinoin, was approved for severe cases and should be stopped when the condition has cleared or it has clearly not worked, in that the condition is still severe after 12 weeks or has not cleared the eczema by 24 weeks.

Source : www.telegraph.co.uk


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Glaxo drug delays kidney cancer progression

An experimental cancer pill from GlaxoSmithKline (GSK.L) reduced the risk of tumour progression or death by 54 percent in advanced kidney cancer patients compared to placebo, trial results showed on Monday.

In spite of this, however, some 4 percent of patients taking the drug died during the course of the study against 3 percent of those on placebo.

Pazopanib belongs to a growing class of anti-cancer drugs that prevent the growth of new blood vessels which feed tumours.

Data presented at the annual American Society for Clinical Oncology meeting in Orlando showed the median progression free survival (PFS) -- the time without tumour growth or death -- for patients on pazopanib was 9.2 months compared with 4.2 months for those on placebo.

"The study shows that pazopanib significantly improved PFS for patients regardless of whether or not they had prior therapy," said Dr. Cora Sternberg of the Department of Medical Oncology, San Camillo and Forlanini Hospitals, Rome.

"While there have been many treatment advances for patients with advanced kidney cancer, there is still a need for medicines that are effective and well-tolerated."

The pivotal Phase III trial involved 435 patients with advanced kidney cancer, or renal cell carcinoma, who had either received no prior drug therapy or had been given cytokine-based treatment.

Side effects associated with the new drug included diarrhoea, hypertension, hair colour change, nausea, anorexia, vomiting and raised liver enzymes, which can signal liver toxicity, as well as rarer cases of thrombosis and haemorrhage.

Investigators attributed death due to the drug in 1.4 percent of patients in the treatment arm.

Glaxo is looking to pazopanib to help boost its position in cancer medicine. The drug was filed for approved with regulators in the United States in December 2008 and was submitted in Europe early this year.

The British-based drugmaker is also currently conducting a head-to-head study comparing pazopanib with Pfizer's (PFE.N) rival kidney cancer treatment, Sutent.

Source : www.reuters.com


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FDA Approves New Drug for Deadly Kidney Cancer

A drug from Novartis has won US approval as a treatment for patients with kidney cancer that has returned after treatment with older drugs.

The US Food and Drug Administration approved the pill to treat renal cell cancer, the most common form of kidney cancer.

The agency said patients tested with Novartis' Afinitor lived more than twice as long without tumor growth as those who didn't receive the drug. The study by the Swiss drugmaker showed Afinitor delayed tumor growth nearly five months, compared with less than two months for patients not taking the drug.

Afinitor works by blocking a protein that helps cancer cells divide and grow. The drug was approved for patients who have already taken Pfizer Inc.'s Sutent and Bayer's Nexavar.

Kidney cancer is resistant to chemotherapy and radiation therapy, and the most effective remedy is usually to surgically remove the kidney. When the cancer is isolated to the kidney, a majority of patients will survive at least five years. If the cancer has spread to other parts of the body, the survival rate is much shorter.

About 13,000 patients died from the disease last year, according to the American Cancer Society.

Basel, Switzerland-based Novartis has submitted the drug for approval in the European Union, Japan, and elsewhere.

Source : www.dddmag.com


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