NICE recommends Kisqali as a cost-effective treatment for advanced breast cancer 

Novartis has announced Kisqali (ribociclib) has been recommended by the National Institute for Health and Care Excellence (NICE) as a cost-effective treatment option for postmenopausal women within England and Wales with advanced breast cancer. 

Postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) locally advanced or metastatic breast cancer will have access to ribociclib, a cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor, as a first-line treatment in combination with an aromatase inhibitor. Ribociclib will be routinely available on the NHS with immediate effect.

“This is a breakthrough moment for the advanced breast cancer community in England and Wales. The combination of ribociclib with an aromatase inhibitor offers women the very real possibility of two years of control of their breast cancer without the need for chemotherapy,” said Dr Alistair Ring, Consultant Medical Oncologist at The Royal Marsden, London. “I see first-hand the devastating impact of this challenging disease on women and their families, so it is really positive news that we can now access ribociclib as a first line treatment.”

In the UK, around 55,000 women are diagnosed with breast cancer each year^4. Thirty percent of women with earlier stages of breast cancer will develop advanced disease^5, which is responsible for 90% of all breast cancer-related deaths¹. Eighty-five percent of women diagnosed with advanced breast cancer will not live longer than five years⁶.

“With the NICE recommendation of ribociclib, postmenopausal women with advanced breast cancer now have a treatment they can fit into their everyday lives,” said Prof Mark Beresford, Co-Chair of the UK Breast Cancer Group (UKBCG), which represents Clinical and Medical Oncologists treating breast cancer in the UK. “This marks a significant milestone in the care we can offer not just through halting disease progression, but also the convenience of taking a daily pill at home. Anything to help women with this incurable disease maintain their quality of life is an essential development.”

“The impact caused by an advanced breast cancer diagnosis can put women and their loved ones through immense emotional strain. Up to 8,300 women a year in England and Wales could now benefit from this new and effective treatment option, allowing them to live longer without their disease worsening, maintain their quality of life and enjoy special moments with their children, family and friends,” said Barak Palatchi, General Manager of Novartis Oncology UK & Ireland. “Under the new NICE process, this is the first time a cancer medicine has been funded so soon after being licensed – showing that the system can work to bring innovation earlier, to benefit patients and the NHS.” 

Ribociclib can be used in combination with letrozole, anastrozole or exemestane – giving oncologists the discretion to select the therapy they believe is most appropriate for each individual patient. The active ingredient for ribociclib is manufactured in the UK at Novartis’ Grimsby site.

The NICE recommendation follows EU licensing by the European Commission in August, which was based on the superior efficacy and an acceptable safety profile of ribociclib plus letrozole versus placebo plus letrozole in the pivotal Phase III MONALEESA-2 trial.

The trial enrolled 668 postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer who received no prior systemic therapy for their advanced breast cancer and showed that ribociclib plus letrozole, an aromatase inhibitor, reduced the risk of progression or death by 43% over placebo plus letrozole (median PFS=25.3 months ([95% CI: 23.0-30.3]) vs. 16.0 months ([95% CI: 13.4-18.2]); HR=0.568 ([95% CI: 0.457-0.704; p<0.0001])2.

More than half of patients (55%) with measurable disease taking ribociclib plus letrozole experienced a tumour size reduction of at least 30%2. Adverse events are generally manageable with stepwise dose modification, allowing most patients to remain on treatment⁷.

The NICE recommendation has been published in its final draft guidance. Novartis is awaiting the NICE Technology Appraisal Guidance, the final step within the NICE approval process, which is scheduled for publication in December 2017 and will be available via the NICE website.

About Kisqali

Kisqali (ribociclib) is a selective cyclin-dependent kinase inhibitor, a class of drugs that help slow the progression of cancer by inhibiting two proteins called cyclin-dependent kinase 4 and 6 (CDK4/6). These proteins, when over-activated, can enable cancer cells to grow and divide rapidly. Targeting CDK4/6 with enhanced precision may play a role in ensuring that cancer cells do not continue to replicate uncontrollably⁸.

Kisqali can be taken with or without food as a once-daily oral dose of 600 mg (three 200 mg tablets) for three weeks, followed by one week off treatment. Kisqali is taken in combination with four weeks of any aromatase inhibitor. 

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

References

[1] American Cancer Society. Unlocking the Mysteries of Metastasis. Available at: http://blogs.cancer.org/expertvoices/2013/01/23/unlocking-the-mysteries-of-metastasis/ [Accessed November 2017]

[2] Hortobagyi G, Stemmer S, Burris H, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole in hormone receptor-positive HER2-negative advanced breast cancer. Presented at the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), June 4, 2017, Chicago, Illinois (abstract #1038).

[3] KISQALI (ribociclib) Summary of Product Characteristics. Camberley, United Kingdom: Novartis Europharm Limited; 2017.

[4] Cancer Research UK [Online]. Breast cancer incidence (invasive) statistics. Available from: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer#heading-Zero [Accessed November 2017].

[5] O’Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. October 2005, 10(suppl.): 20-29.

[6] Cancer Research UK [Online]. Breast cancer survival statistics. Available from: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast-cancer#heading-Three  [Accessed November 2017].

[7] Janni, W. et al. First-line ribociclib plus letrozole for postmenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast cancer (ABC): MONALEESA-2 safety results. J Clin Oncol 35, suppl; abstr 1047 (2017).

[8] Hortobagyi G, Stemmer S, Burris H, et al. Ribociclib as a first-line therapy for HR-positive, advanced breast cancer. New England Journal of Medicine. 2016.