The National Institute for Health and Care Excellence has approved Pfizer’s Ibrance (palbociclib) through the Cancer Drugs Fund (CDF) for use in combination with fulvestrant for the treatment of women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer who have received prior endocrine therapy.
This decision means that palbociclib in combination with fulvestrant will be available on the NHS via the CDF with immediate effect and can be used to treat those who have already had earlier rounds hormone therapy for their advanced disease. It is estimated that there are approximately 3200 women in England living with advanced HR+, HER2- breast cancer who could now be eligible for this treatment.
HR+, HER2- breast cancer is the most common type of breast cancer, accounting for more than 60% of all diagnoses. In its advanced stage, once it has spread to other parts of the body, it is incurable and, in the UK, only 15% of women will live beyond five years. There is, therefore, a real need for innovative treatment options that can delay disease progression and help women feel well for longer.
Palbociclib is a first-in-class, cyclin-dependent kinase (CDK) 4/6 inhibitor which inhibits tumour cell growth. Data from the phase III clinical trial, PALOMA-3, on which this NICE recommendation is based, showed that palbociclib in combination with fulvestrant can delay disease progression by 6.6 months, compared to fulvestrant alone in women who had received prior rounds of hormone therapy (11.2 vs 4.6 months; HR=0.497 [95% CI: 0.398-0.62]). By prolonging progression free survival (PFS), it delays the need for subsequent therapies, including chemotherapy, enabling women to live well whilst their disease remains stable for longer.
Dr Olivia Ashman, Oncology Medical Director, Pfizer UK, said: “This outcome marks a significant milestone for the secondary breast cancer community. We know how important it is for women to have access to treatment options that can delay the progression of their disease and help them live a normal life for longer, and we are delighted that through the CDF this option will be available.”
Professor Nicholas Turner, Professor of Molecular Oncology at The Institute of Cancer Research, London, and Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, was one of the clinical experts on the NICE panel and led the PALOMA-3 trial.
He said: “It is very good news for patients that palbociclib can now be used in combination with fulvestrant for women who have already had earlier rounds of hormone therapy for their advanced breast cancer. This class of medicine remains one of the most important breakthroughs in breast cancer in the last two decades and palbociclib has been shown to slow tumour growth and maintain quality of life, both of which are incredibly important to women living with this type of breast cancer. Today’s news will be warmly welcomed by patients and doctors alike.”