UK regulator approves drug that could extend lives of breast cancer patients

Women with later-stage breast cancer may gain up to three months of extra life after health regulators gave the NHS the green light to prescribe the first new drug to treat the disease in almost a decade.

About 1,500 women a year in England who have locally advanced breast cancer, or whose disease has spread despite two rounds of chemotherapy, will be eligible to receive the life-extending drug. On average, they usually only have two years to live after they have been diagnosed.

The National Institute for Health and Care Excellence (Nice) reversed its previous refusal to approve eribulin because new evidence showed that it could result in “substantial” benefits.

Prof Carole Longson, director of Nice’s centre for health technology evaluation, said: “For this appraisal we’ve been able to consider updated results from the trial used in the original guidance that show women taking eribulin lived on average almost three months longer compared with women taking other treatments.”

“The life expectancy of people for whom eribulin is licensed is short, and quality of life is very important.”

Breast cancer charities said the decision to make the drug routinely available in England could make a big difference to women whose breast cancer had proved resistant to other treatments.

Delyth Morgan, chief executive of Breast Cancer Now, said: “This is immensely positive news. Eribulin is the first breast cancer drug in a decade to be approved and this represents real progress for certain patients in England.

“It offers a crucial life-extending alternative for patients whose breast cancer has become resistant to other therapies, and for those with triple negative disease, who desperately lack treatment options”.

Triple negative cancers are those that do not involve the three molecules that are used to classify breast cancers. About 225 of the potential 1,500 recipients have that form of cancer.

Eribulin is the first new drug to be approved for use in patients with metastatic breast cancer since Gemzar, also known as gemcitabine, was given the go-ahead in January 2007.

Danni Manzi, head of policy and campaigns at Breast Cancer Care, said: “This decision could be life-changing for many women living with incurable breast cancer. Access to this life-extending drug eribulin will offer patients precious extra time to spend with their loved ones. For these patients every day counts.”

She hoped that Nice’s decision will lead to other breast cancer drugs being approved. “With so few treatment options available, it is momentous to bring another medicine to the table,” she said.

Breast cancer in women whose disease has spread to other parts of the body is deemed to be incurable. In those women whose cancer has advanced locally, though, it is seen as still potentially curable.

About 4,000 breast cancer patients have already received eribulin, which is also known as Halaven, since it became available in England through the Cancer Drugs Fund, in March 2011. It is one of the medicines the fund has paid for the most often.

Patients in Wales should also be able to receive the drug as the Welsh NHS follows Nice’s rulings on which medicines represent value for money. Scotland’s equivalent, the Scottish Medicines Consortium, approved the drug in March this year.

Dr Mark Harries, a consultant medical oncologist working with the pharmaceutical company Eisai, who make the drug, said: “I am delighted that women in England with locally advanced or metastatic breast cancer will continue to be able to access eribulin and that the future of this treatment within the NHS is secure. Eribulin significantly improves overall survival in women with this disease and it is therefore an important option against breast cancer.”

Breast cancer is the most common form of cancer in women in England. There are about 45,000 new cases a year, with approximately 300 men contracting it. In 2014, some 9,500 women and 60 men died from the disease.

UK regulator approves drug that could extend lives of breast cancer patients

Skin cancer drug that can extend patient"s lifestyle is advisable for use on NHS

Now, after fresh evidence of the drug’s effectiveness, that restriction has been swept away.

It is estimated ipilimumab could help between 1,000 and 2,000 patients in the UK each year, many of them young.

If the latest draft guidance is approved – which is likely – patients will be eligible for ipilimumab even without first undergoing another form of treatment or taking part in a trial.

Professor Peter Johnson, chief clinician at the charity Cancer Research UK, said after the announcement: “This is good news for melanoma patients: it means that they have the chance to benefit from this new type of treatment without having to go through conventional chemotherapy first.

“Research is showing the huge promise of therapies such as ipilimumab, which manipulate the body’s immune system to fight cancer.

“We’re pleased that Nice and the manufacturer have been able to work together to make this drug available to more patients on the NHS.”

A four-injection course of the treatment costs around £70,000 but the NHS has been given an undisclosed discount to make it more affordable.

Ipilimumab increases lifespan by an average of four months in melanoma patients whose cancer has spread.

But trial data suggests that one in five patients lives for at least three years after treatment.

Each year around 12,800 people in the UK are diagnosed with melanoma, and 2,200 die from the disease, which is notoriously hard to treat in its later stages.

Ipilimumab is a synthetic antibody that effectively takes a brake off the immune system, allowing the immune system’s arsenal of T-cells to target tumours.

It is one of a number of new drugs that act on regulatory systems whose normal role is to keep the immune system under control.

Cancers such as melanoma are known to exploit these immune system “checkpoints” to shield themselves from the body’s defences.

Ipilimumab suppresses a particular checkpoint “brake” called cytotoxic T-lymphocyte antigen 4 (CTLA-4).

Another drug, pembrolizumab, which targets a different checkpoint called PD-1, was recently in the headlines over the “miraculous” response of a trial patient with advanced melonama whose tumours appeared to melt away after treatment.

London TV engineer Warwick Steele, 64, had been given months to live after the cancer spread to his lungs.

Speaking about the case, consultant medical oncologist Dr David Chao, from Royal Hampstead NHS Trust in London, said: “This is one of several new drugs of this type being produced.

“What these early trials are showing is that they are fulfilling their promise ridiculously fast.

“Some of these results are really astonishing; almost jaw-dropping.”

Researchers have tried combining different types of immune checkpoint drug together, with promising results.

In its final draft guidance, Nice said patients with advanced melonoma which is either inoperable or has spread to other parts of the body should be eligible for ipilimumab as a first-line treatment.

Nice chief executive Sir Andrew Dillon said: “We already recommend ipilimumab as a second-line treatment and so we are pleased to be able to propose extending that recommendation to first line treatment too.

“In previous draft guidance issued for consultation early this year, the committee recommended ipilimumab only be used by the NHS for patients in clinical trials.

“However, during the consultation, Bristol-Myers Squibb, the manufacturer of ipilimumab, submitted further information on how well the drug works.

“This information consisted of additional analysis of the existing data which demonstrated the degree to which the approved dose of ipilimumab can extend life when compared with current standard care in the NHS.”

The draft guidance is still subject to appeal.

Final Nice guidance on ipilimumab is due to be issued on July 23.

Skin cancer drug that can extend patient"s lifestyle is advisable for use on NHS