Ibrance (palbociclib) approved by NICE via the Cancer Drugs Fund for women with previously treated HR positive, HER2 negative metastatic breast cancer

Pfizer Ltd, Walton Oaks, UK, 28th November 2019 – Pfizer has today announced that Ibrance (palbociclib) has been recommended by the National Institute for Health and Care Excellence (NICE) 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 3,200 women in England living with advanced HR+, HER2- breast cancer who could now be eligible for this treatment.1

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.”

HR+, HER2- breast cancer is the most common type of breast cancer, accounting for more than 60% of all diagnoses.2 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.3 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.4 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]).5 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.

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.” 

Palbociclib in combination with fulvestrant was approved in Scotland in July 2019. 



About palbociclib: 

• Palbociclib is a first-in-class cyclin-dependent kinase (CDK) 4/6 inhibitor which inhibits tumour cell growth and delays disease progression.4,6,7 

• It is licensed in Europe for the treatment of HR+, HER2-locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or in combination with fulvestrant for women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.8 

• In December 2015, the MHRA granted Pfizer a Promising Innovative Medicine (PIM) designation for palbociclib.9 This designation is given to drugs that are likely to show major advantages over existing UK therapies in the treatment, diagnosis or prevention of life-threatening or seriously debilitating conditions with an unmet need.10 

• Results from the PALOMA-2 study showed that in patients previously untreated for metastatic disease, palbociclib in combination with letrozole increased progression free survival (PFS) to 27.6 months from 14.5 months with letrozole alone (HR 0.563, 95% CI 0.461-0.687; p<0.0001).11 

• Results from the PALOMA-3 trial showed that in patients who have received prior endocrine therapy, there was a statistically significant and clinically meaningful 6.6 month median PFS improvement for palbociclib plus fulvestrant, compared to placebo plus fulvestrant (11.2 vs. 4.6 months; HR=0.50 [95% CI: 0.40- 0.62].5 There was a numerical improvement in OS of nearly 7 months with palbociclib plus fulvestrant compared to placebo plus fulvestrant, although this difference did not reach the prespecified threshold for statistical significance (median OS: 34.9 months [95% CI: 28.8, 40.0] versus 28.0 months [95% CI: 23.6, 34.6]; HR=0.81 [95% CI: 0.64, 1.03], 1-sided p=0.0429). Overall survival is a secondary endpoint of PALOMA-3, and the trial design was not optimised to detect a statistically significant difference in OS.5 

About metastatic breast cancer: 

• Breast cancer is the most commonly diagnosed cancer in women in the UK, with an estimated 55,200 people diagnosed every year.12 

• The number of women living with the condition is set to more than double by 2040 to 1.7 million.13 Breast cancer survival is improving,14 however, 35% of the women who receive a primary breast cancer diagnosis will go on to develop metastatic breast cancer within 10 years.15 

• Metastatic breast cancer occurs when breast cancer cells spread from the first (primary) cancer to other parts of the body. In metastatic breast cancer, the most common sites of metastases are the bones, lungs, liver and brain.16 

• Metastatic breast cancer patients also face significant symptoms and the knowledge that the disease, although treatable, is incurable.17 

Pfizer: Breakthroughs that change patients’ lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. In the UK, Pfizer has its business headquarters in Surrey and is a major supplier of medicines to the NHS. To learn more about our commitments, please visit us at www.pfizer.co.uk or follow us on Twitter (@Pfizer_UK), Facebook (@PfizerUK) and Instagram (@pfizeruk).

2 Onitilo, A.A. et al., Breast cancer subtypes based on ER/PR and Her2 expression: comparison of clinicopathologic features and survival. Clin Med Res, 2009. 7(1-2): p. 4-13. 3 Cancer Research UK. Survival by stage. Available at: https://www.cancerresearchuk.org/about-cancer/breast- cancer/survival [Last accessed November 2019] 4 McCain, J., First-in-Class CDK4/6 Inhibitor Palbociclib Could Usher in a New Wave of Combination Therapies for HR+, HER2- Breast Cancer. P&T journal, 2015. 40(8): p. 511-20.. 5 Turner NC, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. NEJM. 2018; 379; 1926-36 6 Finn R et al., The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advance breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. The Lancet Oncology, 2015. 16(1): p. 25-35. 7 Finn, R.S. et al., Palbociclib and Letrozole in Advanced Breast Cancer. New England Journal of Medicine, 2016. 375(20): p. 1925-36. 8 Medicines.org.uk. (2019). IBRANCE 75 mg hard capsules - Summary of Product Characteristics (SmPC) - (eMC). [online] Available at: https://www.medicines.org.uk/emc/product/4449/smpc [Last accessed November 2019]. 9 MHRA notification of Promising Innovative Medicine (PIM) status for palbociclib. Pfizer data on File. 10 Medicines Healthcare Regulatory Authority. Promising innovative medicine (PIM) designation. Available at: https://www.gov.uk/government/uploads/system/uploads/attachment_data/fil.... [Last accessed June 2019] 11 Rugo, H., Finn, R., Diéras, V., Ettl, J., Lipatov, O., Joy, A., Harbeck, N., Castrellon, A., Iyer, S., Lu, D., Mori, A., Gauthier, E., Bartlett, C., Gelmon, K. and Slamon, D. (2019). Palbociclib plus letrozole as first-line therapy in estrogen receptor- positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Research and Treatment, 174(3), pp.719-729 12 Cancer Research UK Breast cancer statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/st... Zero [Last Accessed November 2017] 13 Maddams, J., M. Utley, and H. Moller, Projections of cancer prevalence in the United Kingdom, 2010-2040. Br J Cancer, 2012. 107(7): p. 1195-202. 14 Cancer Research UK Breast cancer statistics, Breast cancer survival. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/s... Three [Last accessed November 2019] 15 Nice.org.uk. (2009). Available at: https://www.nice.org.uk/guidance/cg81/evidence/needs-assessment-pdf-2422... [Last accessed November 2019 2019] 16 The Christie NHS Foundation Trust. Breast Cancer – Secondary. Available at: https://www.christie.nhs.uk/patients-and- visitors/your-treatment-and-care/types-of-cancer/breast-cancer-secondary/ [Last accessed November 2019] 17 Cardoso, F., et al., ESO-ESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Breast, 2014. 23(5): p. 489-502. 

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