Herceptin set for approval in early breast cancer
pharmafile | April 28, 2006 | News story | Sales and Marketing |
Herceptin, the breast cancer drug at the centre of a long-running controversy could soon be available to thousands more women across Europe, after it gained preliminary approval to treat early stages of the disease.
Data suggesting that Herceptin could stop cancer returning in women with early stage HER2-positive breast cancer was published last year, and a wave of publicity helped raise public demand for it, even though it had yet to gain safety and efficacy clearance from regulators.
In the UK, a number of women have fought their local PCTs for access to the drug, most notably Ann Marie Rogers, who took her case in the High Court and won.
These women have all been prescribed the drug outside its official licence, but it is now closer to wider availability, with experts at Europe's CHMP recommending it for approval.
Final European clearance is expected within a few months, after which point manufacturers Roche can begin marketing Herceptin's new use to doctors - although few will be unaware of the data, such has been the publicity around the drug.
In the UK, clinical and cost effectiveness body NICE is expected to give its judgement in July, but it remains uncertain if the body will recommend its use on the NHS based on the current evidence.
The drug would cost 20,000 pounds a year to treat women with early stage breast cancer, and could in total cost the NHS an extra 100 million pounds a year.
Some observers say the current cost-effectiveness evidence is not overwhelmingly favourable, but Roche believe the data from the HERA trial of Herceptin should be enough to convince bodies such as NICE of the drug's value.
"The results from four large-scale trials speak for themselves: Herceptin consistently reduces the risk of relapse when used in early stages, providing the best chance of long-term survival to women with an extremely aggressive form of breast cancer," said Ed Holdener, head of Roche's global pharma development.
"The CHMP's timely decision represents a significant milestone, bringing patients and the medical community one step closer to broadly accessing this effective therapy in the EU."
Herceptin is the first ever drug to be put through the CHMPs new fast-track appraisal system, which has been introduced to get innovative new medicines to patients more quickly.
The CHMP noted that there are concerns about the drug's side-effects, particularly cardio-toxicity, which could lead to life-threatening heart problems.
Roche has agreed to perform further studies on the long-term effects of Herceptin, particularly in relation to cardiovascular risk. The EMEA says the company will make efforts to identify patients at a higher risk to guarantee that they are carefully monitored.
