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

National Institute for Health and Care Excellence gives NHS go-ahead to prescribe eribulin after new evidence shows drug may have ‘substantial’ benefits

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.

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Denis Campbell Health policy editor

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