Twice-a-day pill for advanced breast cancer approved
The life-extending drug, called capivasertib (Truqap), will benefit up to 3,000 women every year.
The approval comes after a U-turn by the National Institute of Care and Health Excellence (Nice), which initially rejected the drug after assessing its cost and benefit to patients.
To be eligible for the treatment, women will have to be diagnosed with a certain type of breast cancer, called hormone receptor (HR)-positive HER2-negative breast cancer. It will also need to have spread to another part of the body.
It is the most common form of incurable breast cancer but treatment options have been limited.
The new drug is suitable for women whose tumours have mutations in the PIK3CA, AKT1 or PTEN genes, which are found in approximately half of patients with this form of breast cancer.
The drug, made by AstraZeneca, works by blocking the action of an abnormal protein that drives the cancer cells to multiply, and so slows their spread.
Results from a clinical trial showed that capivasertib plus the hormone therapy fulvestrant increased the time before the cancer got worse by around 4.2 months compared with placebo plus fulvestrant – from 3.1 months to 7.3 months.
Decades of research
The approval follows decades of research by scientists from the Institute of Cancer Research (ICR) in London.
Prof Nicholas Turner, from the ICR and the Royal Marsden NHS Foundation Trust, led a major trial into the drug.
'This positive Nice recommendation means that thousands of NHS patients with advanced breast cancer with these specific biomarkers can now receive this innovative targeted treatment to keep their cancer from progressing for longer,' he said.
'It's an immensely rewarding moment to see this drug provide patients with a treatment option and precious extra time with their families.'
About 56,000 people are diagnosed with breast cancer in the UK every year.
Tom Keith Roach, president of AstraZeneca UK, said: 'This is a fantastic story of what UK science can do.
'The partnership between AstraZeneca, the Institute of Cancer Research, and Cancer Research Technology underscores the potential of UK life sciences, which we are working with government to unlock on behalf of patients and the UK growth agenda.'
'Success story for British science'
Prof Kristian Helin, chief executive of the ICR, said: 'Around half of patients with this kind of breast cancer have mutations in one or more of the genes, and for these patients capivasertib can halt disease progression.'
He said it was 'a great success story for British science'.
The treatment will be immediately funded through a ring-fenced pot of money to roll out cancer drugs in England.
Prof Paul Workman, former chief executive of the ICR and researcher in the drug discovery project, said it was a 'landmark moment'.
Claire Rowney, chief executive of Breast Cancer Now, criticised the initial rejection by Nice as causing unnecessary delays for women.
'This happens too often and urgent action must be taken to ensure the quick approval of breast cancer drugs so they can be made available promptly to those who need them,' she said.
She called on NHS England to 'put in place prompt genetic testing' to identify those who would benefit.
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