Keytruda is for women with incurable secondary triple negative breast cancer and its aim is to slow disease progression.
24 May 2022
Around 100 women a year with advanced breast cancer will be able to try a new type of immunotherapy on the NHS.
The National Institute for Health and Care Excellence (Nice) has overturned its draft rejection of Keytruda (pembrolizumab) and has said women can take the drug in combination with chemotherapy.
The drug is for women with incurable secondary triple negative breast cancer and its aim is to slow disease progression – buying patients extra time.
Baroness Delyth Morgan, chief executive of Breast Cancer Now, said the move was “absolutely fantastic news for around 100 patients” every year with the disease.
She added: “Following its worrying provisional rejection by Nice earlier this year, the reversal of this decision now brings hope to eligible women for whom it could bring precious additional time before their disease progresses and more months to live and spend time with loved ones and doing what matters most to them.
“Triple negative breast cancer is a particularly aggressive form of breast cancer, often with poorer outcomes.
“Whilst immunotherapy treatment atezolizumab was made available on the NHS in 2020, there has remained an unmet need for a group of patients who could not receive this combination, which is why it is so vital that alternative treatments, such as pembrolizumab, quickly reach those still desperately in need of new, effective treatment options.
“Despite this positive news, we now also desperately need to see progress on the Nice appraisal of Trodelvy, which is another potentially life-extending drug for certain people with secondary breast cancer, that was devastatingly provisionally rejected in April.
“A recent delay to the second Nice committee meeting has caused further anxiety for these patients, which is unacceptable.
“Together, Gilead, Nice and NHS England must find a solution to ensure this drug is made routinely available on the NHS.”
Keytruda is used with chemotherapy in women with triple negative breast cancer whose tumours express PD-L1 with a combined positive score (CPS – the number of PD-L1 positive cells in relation to tumour cells) greater than or equal to 10.
They must also not have had chemotherapy for advanced disease, and they qualify for treatment if surgery is not possible to remove the tumour.
Nice said that following its previous rejection, manufacturer Merck Sharp and Dohme proposed that the drug combination should be restricted to people whose tumours express PD-L1 with a CPS greater than or equal to 10.
This meant Nice was able to look again and pass the drug, which works by blocking the activity of PD-L1, helping the person’s own immune cells to attack cancer.
Helen Knight, interim director of medicines evaluation at Nice, said: “I am pleased the company has been able to work constructively with us to find solutions to the issues highlighted in our previous draft guidance.
“People who were not able to access atezolizumab, another Nice-recommended immunotherapy, now have an important new option that can help them live longer and spend more precious time with their loved ones.
“So, although our recommendation is for a narrower population than pembrolizumab combination is licensed for, it means the maximum number of people with advanced triple negative breast cancer now have access to effective treatments.”
It comes as a poll for Breast Cancer Now of 1,007 women with breast cancer found 44% said the disease negatively affected their body image and 25% said the same for their sense of identity.
Overall, 37% said their diagnosis worsened their mental health and self-esteem.