Around 100 women a year with advanced breast cancer can try a new type of immunotherapy at the NHS.
The National Institute for Health and Care Excellence (Nice) has reversed its draft rejecting Keytruda (pembrolizumab), saying women can take the drug in combination with chemotherapy.
The drug is intended for women with incurable secondary triple-negative breast cancer and is designed to slow the progression of the disease – giving patients extra time.
Baroness Delyth Morgan, chief executive of Breast Cancer Now, said the move was “absolutely fantastic news for around 100 patients” each year with the disease.
She added: “Following the worrying provisional rejection by Nice earlier this year, the reversal of that decision now brings hope to eligible women who it could bring valuable extra time before their illness progresses and more months to live and spend time with loved ones.” to spend and do what is most important to them.
“Triple-negative breast cancer is a particularly aggressive form of breast cancer, often with poorer outcomes.
“While immunotherapy atezolizumab was made available in the NHS in 2020, there remains an unmet need for a group of patients who have not been able to receive this combination, which is why it is so important that alternative treatments such as pembrolizumab reach these quickly, which are still urgently needed new, effective treatment options.
“Despite this positive news, we now also urgently need to see progress on the Nice review of Trodelvy, another potentially life-prolonging drug for certain patients with secondary breast cancer, which was devastatingly provisionally rejected in April.
“A recent delay in the second Nice Committee meeting has raised further concerns among these patients, which is unacceptable.
“Together Gilead, Nice and NHS England must find a solution to ensure this drug is routinely made available on the NHS.”
Keytruda is used with chemotherapy in women with triple-negative breast cancer whose tumors express PD-L1 with a combined positive score (CPS – the number of PD-L1 positive cells relative to tumor cells) of at least 10.
They must also not have received chemotherapy for advanced disease, and they may be eligible for treatment if surgery to remove the tumor is not possible.
Nice said that following its previous rejection, manufacturer Merck Sharp and Dohme proposed restricting the drug combination to people whose tumors express PD-L1 with a CPS greater than or equal to 10.
This meant Nice was able to look again and administer the drug, which blocks the activity of PD-L1 and helps the person’s own immune cells attack cancer.
Helen Knight, Interim Director of Medicines Evaluation at Nice, said: “I am pleased that the company was able to work constructively with us to find solutions to the issues highlighted in our previous draft guidance.
“People who didn’t have access to atezolizumab, another immunotherapy recommended by Nice, now have an important new option that can help them live longer and spend more quality time with loved ones.
“Although our recommendation is for a smaller population than the pembrolizumab combination is approved for, it means the maximum number of people with advanced triple-negative breast cancer now have access to effective treatments.”
A Breast Cancer Now survey of 1,007 women with breast cancer found that 44% said the disease negatively affected their body image, and 25% said the same for their sense of identity.
Overall, 37% said their diagnosis had worsened their mental health and self-esteem.