BREAST CANCER VICTIMS DENIED LIFELINE

Wonder drug fast-tracked in US is held up by EU and NHS red tape

THOUSANDS of breast cancer sufferers face being denied a ‘game- changing drug’ because of red tape and cost concerns.

A landmark trial shows the daily pill halts advanced tumours in their tracks and enables patients to lead normal lives.

American watchdogs have given fast-track approval and the treatment is already being prescribed to 27,000 women in the US.

It is not available in Britain however because the EU’s medicines regulator has so far failed to reach a decision despite a ten-month review process.

Even when the pill is given a licence – probably at the end of this year – it will almost certainly be rejected as too costly by the Health Service rationing body NICE.

Called palbociclib, it could help up to 25,000 British women who have few treatment options other than drugs that temporarily slow the spread of their tumours.

Gisela Stuart, a former Labour health minister, condemned the regulatory delays, suggesting bureaucracy was failing women.

But a leading cancer charity said the bigger issue was the expected

snub from NICE for a drug costing £7,000 a month.

The research unveiled in Chicago yesterday at the American Society for Clinical Oncology conference – the world’s largest cancer meeting – showed that palbociclib kept tumours at bay on average for two years – nearly twice as long as standard treatments.

The ongoing trial involves 521 women with advanced breast cancer of whom half are taking palbociclib, and the rest standard tablets. In the first group, tumours have been held at bay for an average of 25 months. In the second group it is 14 and a half months.

Researchers expect many patients taking palbociclib will survive for years.

Described by experts as a game- changer, it works by blocking proteins that would otherwise fuel tumour growth.

Baroness Delyth Morgan, of the charity Breast Cancer Now, said: ‘These findings are real evidence of progression-free survival and our anxiety levels have kicked in immediately because we are really worried patients are not going to get it in the clinic.

‘My worry is that it will get taken up in other countries.

‘This is a really significant step forward in the management in advanced breast can- cer. It could mean seeing the birth of your grandchild, being around long enough to see your children graduate.

‘We’re talking about an average of ten months but it could be more.’

One reason for the delay in assessment by the European Medicines Agency, the EU drugs watchdog, is that manufacturer Pfizer did not submit all of its trial data.

But Mrs Stuart, who chairs the Vote Leave campaign, said the case was another example of EU red tape worsening cancer care.

‘The bureaucratic and schlerotic nature of Brussels is failing thousands of women across Europe by delaying access to life-extending drugs,’ she said.

She said the EU had previously worsened cancer care through a botched scheme aimed at speeding up access to breakthrough drugs – the Clinical Trials Directive – but which resulted in them taking longer to get the green light.

‘The EU has a disastrous record on cancer care,’ she added. ‘ The Clinical Trials Directive was devastating for cancer research, increasing costs and delaying the start of trials.’

Dr Harold Burstein, an associate medical professor at Harvard Medical School who sits on the American Society for Clinical Oncology’s breast cancer committee, said the process for approving breakthrough drugs tended to be far quicker in the US than in Europe.

‘ The US Food and Drug Administration has been able to move drugs into the marketplace more quickly,’ he added.

‘They seem more willing to act on dramatic results shown in small numbers of patients.’

The European Medicines Agency, which is based in London, is an arm of the EU responsible for licensing all new drugs.

It carries out rigorous checks to ensure treatments are safe and effective – a process which typically takes 14 months.

Some studies have found that this is on average twice as long as the FDA.

‘A significant step forward’