On the 05 June 2020, the Herald Sun published an article regarding the announcement of a cost-free access program of a CDK 4/6 inhibitor supplied by Novartis Australia named Kisqali® (ribociclib).
Novartis Australia is extremely proud of this new program but there is a point relating to eligible patients that requires clarification. The correct details are outlined below.
The new access program (SPARK Plus), launched by Novartis Australia, is for eligible Australian patients with HR+, HER2- advanced breast cancer, when used in combination with fulvestrant and in line with the current approved Therapeutic Goods Administration (TGA) indication.1 Please note fulvestrant is not marketed by Novartis or provided as part of this access program.
Kisqali is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with an aromatase inhibitor or fulvestrant, as initial endocrine-based therapy or following prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Kisqali in combination with fulvestrant and/or as a second-line treatment following an alternative initial endocrine therapy is not currently available on the Pharmaceutical Benefits Scheme (PBS). Novartis has recently made a submission to the Pharmaceutical Benefits Advisory Committee (PBAC) for reimbursement consideration.
Since 2018, patients have been able to access Kisqali on the PBS in combination with an NSAI (non-steroidal aromatase inhibitor) (anastrazole or letrozole) as initial endocrine-based therapy in post-menopausal women with hormone receptor HR+ HER2- locally advanced or metastatic breast cancer.2 Younger women rendered menopausal through hormonal treatment are also covered on the PBS.2 Breast cancer patients should discuss with their treating clinicians all available treatment options which may be suitable for them.
Novartis is proud to launch the SPARK Plus Access Program – an important milestone for breast cancer treatment. This follows the 2017 Kisqali SPARK Access Program3 and Novartis’ 20-year commitment to providing treatment options for clinicians and breast cancer patients in Australia.4-10
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PBS Information: Authority Required. Refer to the PBS Schedule for full Authority information. This product is not listed on the PBS for use in combination with fulvestrant.
About Kisqali Kisqali® is an oral CDK4/6 inhibitor used in the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/ HER2-), advanced or metastatic breast cancer and works by blocking cell cycle progression, preventing the uncontrolled proliferation of abnormal cells.
TGA approved indication1 Kisqali® is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant as initial endocrine-based therapy or following prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Important safety information1 The most frequently observed adverse reactions (≥10%) are neutropenia, nausea, leukopenia, alopecia, anaemia, vomiting, rash and pruritus. Kisqali® is contraindicated in patients with corrected QT interval (QTcF) >450 milliseconds (ms) prior to treatment, or who have long QT syndrome, or who are at significant risk of developing QTc prolongation. Kisqali® is contraindicated in patients with hypersensitivity to ribociclib succinate or any of the excipients, which include soya lecithin.
About Novartis in Advanced Breast Cancer Novartis tackles breast cancer with superior science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.
About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. We believe continued R&D is essential to innovation and in Australia last year we invested 9.4M in clinical trials. Novartis products reach nearly 1 billion people globally and we are finding innovative ways to expand access to our latest treatments. About 105,000 people of more than 140 nationalities work at Novartis around the world. Novartis has more than 60 years’ history in Australia and employ around 600 across its two divisions. For more information, please visit http://www.novartis.com.au.
Slamon DJ, Neven P, Chia S, et al. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018 Aug 20;36(24):2465-247.
Slamon DJ, et al. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Eng J Med. 2020 Feb 6;382(6):514-524.