Novartis’ advanced breast cancer drug Kisqali® (ribociclib) recommended for NHS funding in Scotland, offering women an average of two years without their disease getting worse
Mar 12, 2018
Advanced breast cancer is an incurable disease, responsible for 90 per cent of all breast cancer-related deaths1
Ribociclib in combination with an aromatase inhibitor is a new and effective treatment option for women in Scotland with the most common form of advanced breast cancer, giving them the possibility of living on average two years without their disease progressing2
Ribociclib is taken orally once daily, allowing women with advanced breast cancer to take their treatment at home, with or without food3
Camberley, UK, March 12th, 2018 – Novartis today announced Kisqali® (ribociclib) has been recommended for routine use on the NHS by the Scottish Medicines Consortium (SMC) for postmenopausal women within Scotland with advanced breast cancer.
Postmenopausal women with HR+/HER2- (hormone receptor positive, human epidermal growth factor receptor-2 negative) locally advanced or metastatic breast cancer will have access to ribociclib, a CDK4/6 (cyclin-dependent kinase 4 and 6) inhibitor, as a first-line treatment in combination with an aromatase inhibitor. The cost-effective treatment will be available on the NHS in Scotland with immediate effect.
“Ribociclib in combination with an aromatase inhibitor offers the realistic possibility of two years’ control of a woman’s advanced breast cancer without the need for chemotherapy, as well as the convenience of a daily pill that can be taken in the comfort of their own home,” said Professor David Cameron, professor of oncology and director of cancer services at NHS Lothian. “Being diagnosed with advanced breast cancer can be devastating for both the patient and their loved ones, and I whole heartedly welcome the recommendation of ribociclib as an effective, first-line treatment for use on the NHS in Scotland.”
In the UK, around 55,000 women are diagnosed with breast cancer each year4. Thirty per cent of women with earlier stages of breast cancer will develop advanced disease5, which is responsible for 90% of all breast cancer-related deaths1. Eighty-five per cent of women initially diagnosed with advanced breast cancer will not live longer than five years6.
“We are pleased that ribociclib in combination with an aromatase inhibitor is now available for use on the NHS throughout the UK,” said Mari Scheiffele, General Manager of Novartis Oncology UK & Ireland. “With this latest SMC recommendation, over 700 women with advanced breast cancer in Scotland could benefit from ribociclib treatment enabling them to maintain their quality of life and enjoy precious time with their loved ones.”
The SMC recommendation follows the positive recommendation by The National Institute for Health and Care Excellence (NICE) in November 2017, 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]). More than half of patients (55%) with measurable disease taking ribociclib plus letrozole experienced a tumour size reduction of at least 30%2. The most common adverse events in the ribociclib plus letrozole arm included: neutropenia (low white blood cell count), nausea, fatigue and diarrhoea2. Adverse events are generally manageable with stepwise dose modification, allowing most patients to remain on treatment7.
About Kisqali® (ribociclib) 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)2. 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 with any aromatase inhibitor is taken in a once-daily oral dose of 600 mg (three 200 mg tablets) for three weeks, with or without food, followed by one week of the aromatase inhibitor alone.
Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
About the Kisqali Clinical Trial Programme Novartis is continuing to assess Kisqali through the robust MONALEESA clinical trial program, which includes two additional Phase III trials, MONALEESA-3 (NCT02422615) and MONALEESA-7 (NCT02278120) that are evaluating Kisqali in combination with multiple endocrine therapy partners across a broad range of patients, including premenopausal women. MONALEESA-3 is evaluating Kisqali in combination with fulvestrant compared to fulvestrant alone in postmenopausal women with HR+/HER2- advanced breast cancer who have received no or a maximum of one prior endocrine therapy. MONALEESA-7 is investigating Kisqali in combination with endocrine therapy and goserelin compared to endocrine therapy and goserelin alone in premenopausal women with HR+/HER2- advanced breast cancer who have not previously received endocrine therapy. These trials are fully enrolled.
The CompLEEment study (NCT02941926) is evaluating the safety and efficacy of Kisqali plus letrozole in men and pre- or postmenopausal women with HR+/HER2- advanced breast cancer with no prior hormonal therapy for advanced disease. The open-label, multi-centres, Phase IIIb CompLEEment-1 trial is fully enrolled at 26 sites across the UK.
About Novartis in Advanced Breast Cancer For more than 25 years, Novartis has been at the forefront of driving scientific advancements for breast cancer patients and improving clinical practice in collaboration with the global community. With one of the most diverse breast cancer pipelines and the largest number of breast cancer compounds in development, Novartis leads the industry in discovery of new therapies and combinations, especially in HR+ advanced breast cancer, the most common form of the disease.
About Novartis Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
In the UK, Novartis develops, manufactures and markets innovative medicines, devices and diagnostic tests which help improve patient outcomes. Based on four sites across the north and south of England, we employ approximately 1,500 people to serve healthcare needs across the whole of the UK, as well as supporting the global operations of Novartis by manufacturing the active pharmaceutical ingredients used worldwide in many medicines. In 2016 Novartis in the UK invested almost £40million in R&D and is the largest commercial sponsor of clinical trials. For more information, please visit www.novartis.co.uk.
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).
KISQALI® (ribociclib) Summary of Product Characteristics. Camberley, United Kingdom: Novartis Europharm Limited; 2017.
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).
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.