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NICE (the National Institute for Health and Clinical Excellence) has published draft guidance on Herceptin, just two weeks after the drug was licensed by the EU regulatory authorities for use in early breast cancer. The draft guidance recommends the drug for women with early stage HER2-positive breast cancer, except where there are concerns about the woman’s cardiac function.
The press release is available from the NICE website: www.nice.org.uk
Karol Sikora, Professor of Cancer Medicine and honorary Consultant Oncologist at at Imperial College School of Medicine, Hammersmith Hospital, said:
“It’s gratifying to see NICE respond so quickly to something that will clearly affect over 30,000 women a year. But over the next five years many other high cost cancer drugs will come on the market and it’s important that we have robust and rapid decision making processes in place to deal with these.”
Dr Andrew Wardley, Consultant Medical Oncologist at Christies Hospital, Manchester, said:
“The latest results from the HERA (Herceptin Adjuvant Trial) showed that disease free survival for patients who received herceptin was improved by 36%. When patients were given herceptin 80.65 were alive after 3 years without any reoccurrence of cancer compared to 74% who had other treatments. Survival rates for those who had been treated by herceptin were around 92% compared to around 89% to those who were treated with standard treatments. This is an improvement between 34-37%.”
Professor Peter Rigby, The Institute of Cancer Research, said:
“We are delighted with this proposal as it is great news for women with HER2 positive breast cancer who often have poor prognosis. Up to one-quarter of women with breast cancer have the HER2 positive form of the disease so the decision to extend licensing will improve survival for a greater number of women in this group.”
Prof Janet Darbyshire, Director of MRC Clinical Trials Unit, said:
“This is good news for an important sub-group of women with breast cancer. Like all drugs, Herceptin is not without risk and the NICE guidance highlights the importance of screening women and not offering to those at increased risk of cardiovascular toxicity.”
Dr Rob Coleman, breast cancer specialist at Sheffield University, said:
“The NICE draft guidance is entirely in line with the views of breast cancer specialists that this unprecedented development in the treatment of breast cancer should be made available to all suitable patients. Although Herceptin is an expensive treatment, the large impact it makes on reducing both breast cancer recurrence and death from the disease makes it a highly cost effective intervention for appropriate patients.”
Professor Ian Smith, Head of the Breast Unit at the Royal Marsden Hospital, London and the lead UK investigator for HERA, said:
“Herceptin is the most important treatment advance ever for women with early stage HER2 positive breast cancer and therefore today’s announcement is excellent news for all these women throughout the UK.
“Testing for HER2 status on diagnosis and access to Herceptin treatment should now be made available as soon as possible to all patients likely to benefit.”
Kate Law, Cancer Research UK’s Head of Clinical Trials, said:
“Herceptin will now be available to everyone who could benefit from it, regardless of where they live.
“We must remember that Herceptin is only suitable in about one in five cases of breast cancer. So it’s essential not to create a climate of false hope for women, where Herceptin is seen as a miracle cure suitable for everyone with breast cancer.
“NICE appraised Herceptin in record and we hope it will be able to apply the same processes to other important drugs that are in the pipeline. Time is of the essence when treating cancer patients, so it is imperative that effective new treatments be made available for them as quickly as possible.”
Dr Stephen Johnston, Consultant Medical Oncologist and Director of Clinical R&D at the Royal Marsden Hospital, said:
“I warmly welcome this guidance from NICE, and the fact that this drug has now been shown to save lives actually makes it a very effective use of NHS funds. For clinicians like me who are treating breast cancer patients the decision is a no-brainer because we know that this treatment is extremely effective and will prolong survival for those 20% of women with the more aggressive HER2-positive type of breast cancer.
“For the first time NICE guidance has been issued alongside the approval of a license for the drug from the regulatory authorities. Both organizations review the same clinical data, so it is imperative that NICE continues to produce immediate and relevant guidance so that future patients are not denied approved and effective treatments.”
Jo Tanner, chief executive of the Coalition for Medical Progress (CMP), said:
“It is good to see that the licensing of Herceptin, which was developed using monkeys, has been so broadly welcomed by patients and practitioners, in the same week primate research has been so much in the news. So-called wonder drugs like Herceptin are made possible by research using animals, which is why continuation of such research is so important.”
Dr Simon Festing, director of the Research Defence Society (RDS), said:
“More lives will be saved thanks to laboratory animals. Like other monoclonal antibody treatments, this advance for women with breast cancer is heavily dependent on animal research. Monoclonal antibodies themselves were discovered in mice 30 years ago, development of the drug depended crucially on mice, and Herceptin was safety tested in monkeys.”