KISQALI Achieves Significant Market Growth, Strengthening Its Position in Breast Cancer and CDK4/6 Inhibitors Segment
DelveInsight's ' KISQALI Market Size, Forecast, and Market Insight Report ' highlights the details around KISQALI, a cyclin-dependent kinase (CDK4/6 inhibitor). The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of KISQALI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Novartis' KISQALI (ribociclib) Overview
KISQALI (ribociclib) is a targeted cyclin-dependent kinase inhibitor, a type of drug that helps slow cancer progression by blocking two proteins, cyclin-dependent kinase 4 and 6 (CDK4/6). When these proteins are overactive, they can cause cancer cells to grow and divide too quickly. By specifically targeting CDK4/6, KISQALI aims to prevent cancer cells from replicating uncontrollably. KISQALI was developed by Novartis in collaboration with Astex Pharmaceuticals. In addition to its FDA approval for early breast cancer (EBC) patients in the US, KISQALI is undergoing regulatory reviews in other regions, including the EU and China.
KISQALI has received approval for treating metastatic breast cancer (MBC) in 99 countries, including the US and EU. In the US, it is approved for adults with HR+/HER2- advanced or MBC in combination with an aromatase inhibitor (AI) as initial endocrine therapy (ET) or fulvestrant as initial ET or after disease progression. In the EU, it is approved for women with HR+/HER2- advanced or MBC in combination with an AI or fulvestrant as initial ET or after disease progression. In pre- or peri-menopausal women, the ET should be combined with a luteinizing hormone-releasing hormone agonist.
In the context of MBC, KISQALI has consistently shown significant overall survival benefits in three Phase III trials. The NCCN Guidelines for breast cancer recommend KISQALI (ribociclib) as the only Category 1 preferred CDK4/6 inhibitor for first-line treatment in HR+/HER2- patients when combined with an AI, making KISQALI the preferred first-line treatment in the US for this patient group. Additionally, KISQALI received the highest score among CDK4/6 inhibitors on the ESMO Magnitude of Clinical Benefit Scale, scoring five out of five for first-line treatment of pre-menopausal patients with HR+/HER2- advanced breast cancer. KISQALI, when combined with either letrozole or fulvestrant, earned a four out of five rating for post-menopausal patients with HR+/HER2- advanced breast cancer in the first-line setting.
KISQALI Dosage and Administration
The suggested KISQALI dosage is 600 mg (equivalent to three 200 mg film-coated tablets) taken orally once a day for 21 consecutive days, followed by a 7-day break from treatment, making a full cycle of 28 days. KISQALI can be taken with or without food. When used in combination with KISQALI, the recommended dose of fulvestrant is 500 mg, administered on Days 1, 15, 29, and then once a month thereafter.
KISAQALI at a Glance
Drug Name: KISQALI (ribociclib)
Molecule type: Small molecule
Developer: Novartis
Primary Indication: HR+/HER2− breast cancer
Mechanism of action: Cyclin-dependent kinases 4 and 6 inhibitor
Route of administration: Oral
CDK4/6 inhibitors are a type of targeted cancer therapy that work by blocking the function of cyclin-dependent kinases 4 and 6—enzymes crucial for regulating the cell cycle, particularly the progression from the G1 to S phase, where cells begin DNA replication. By inhibiting these kinases, the drugs effectively stop cancer cell proliferation, leading to growth arrest and potentially cell death. This precise mechanism makes them especially effective in treating hormone receptor-positive, HER2-negative breast cancers, among other types.
The introduction and approval of CDK4/6 inhibitors have significantly reshaped the treatment approach for HR+/HER2− metastatic breast cancer. Currently, three main selective CDK4/6 inhibitors, IBRANCE (palbociclib), KISQALI (ribociclib), and VERZENIO (abemaciclib), are commonly used in combination with endocrine therapy as the first-line treatment. Notably, the NCCN now recommends KISQALI as the preferred first-line option for metastatic cases. Once endocrine and targeted therapies no longer work, chemotherapy and antibody-drug conjugates (ADCs) are typically used.
IBRANCE remains the market leader among CDK4/6 inhibitors, with around 70% of U.S. patients receiving it when prescribed a drug in this class. Looking ahead, there is strong potential to extend the use of CDK4/6 inhibitors beyond HR+/HER2− advanced breast cancer. According to DelveInsight, market growth in the 7MM is expected to be fueled by rising cancer incidence, greater awareness and access to treatment, and an active pipeline of new indications.
Emerging Competitors of KISQALI
Some of the CDK4/6 inhibitors in the pipeline include Lerociclib (G1 Therapeutics and Pepper Bio), Atirmociclib (Pfizer), PRT3645 (Prelude Therapeutics), Trilaciclib (G1 Therapeutics), SPH4336 (Shanghai Pharma Biotherapeutics), Dalpiciclib (Jiangsu Hengrui Pharmaceuticals), BGB-43395 (BeiGene), BTX-9341 (Biotheryx), and Euthare-155008 (Shengke Pharmaceuticals), among others.
In May 2024, G1 Therapeutics and Pepper Bio announced a global licensing agreement (excluding Asia-Pacific) for lerociclib, a selective CDK4/6 inhibitor. Using their COMPASS platform, Pepper Bio identified CDK4/6 as key targets for Hepatocellular carcinoma, with preclinical models showing superior efficacy. Lerociclib is now advancing to Phase II trials.
Key Milestones of KISQALI
In December 2024, Novartis shared updated findings from the pivotal Phase III NATALEE trial of KISQALI, highlighting its prolonged effectiveness even after treatment ends when used alongside endocrine therapy (ET). The results demonstrated a 28.5% sustained reduction in the risk of distant recurrence (HR=0.715; 95% CI 0.604–0.847; nominal P<0.0001) compared to ET alone in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (EBC).
In November 2024, Novartis announced that the European Commission (EC) had approved KISQALI, in combination with an aromatase inhibitor (AI), for use as adjuvant treatment in patients with HR-positive HER2-negative early breast cancer who are at high risk of recurrence.
In September 2024, Novartis announced that the FDA has approved KISQALI, in combination with an aromatase inhibitor (AI), for adjuvant treatment of patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) stage II and III early breast cancer (EBC) who are at high risk of recurrence — including individuals with node-negative (N0) disease.
In September 2020, Novartis proudly shared that KISQALI received the highest possible score—five out of five—on the European Society for Medical Oncology's Magnitude of Clinical Benefit Scale (ESMO-MCBS) for use as a first-line treatment in premenopausal patients with hormone receptor-positive, HER2-negative (HR+/HER2-) advanced or metastatic breast cancer.
In July 2018, Novartis received a new approval from the FDA for KISQALI (ribociclib) to treat women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2−) advanced or metastatic breast cancer.
In March 2017, the FDA approved KISQALI, in combination with an aromatase inhibitor, as a first-line endocrine-based treatment for postmenopausal women with hormone receptor-positive, HER2-negative (HR+/HER2−) advanced or metastatic breast cancer.
Discover how KISQALI CDK4/6 inhibitor is shaping the breast cancer treatment landscape @ KISQALI Cost
KISQALI Market Dynamics
KISQALI (ribociclib) is a CDK4/6 inhibitor used primarily in the treatment of HR-positive, HER2-negative breast cancer. Since its approval in 2017 by the FDA, it has become a key player in the competitive oncology market. The drug works by inhibiting cyclin-dependent kinases 4 and 6, which are responsible for the progression of many cancers, including breast cancer. KISQALI is typically used in combination with aromatase inhibitors or letrozole, offering a therapeutic advantage by enhancing anti-tumor efficacy while also maintaining manageable safety profiles.
The market dynamics for KISQALI are heavily influenced by the broader competitive landscape of CDK4/6 inhibitors, with notable competitors including IBRANCE (palbociclib) and VERZENIO (abemaciclib). These drugs are all vying for market share in a segment that is expected to grow significantly due to increasing breast cancer diagnoses and the demand for targeted therapies. KISQALI has carved a niche for itself with favorable clinical trial data, including its ability to deliver improved progression-free survival rates, which is appealing to oncologists and healthcare providers.
However, pricing pressures, especially in markets with significant healthcare budget constraints, and the rising popularity of combination therapies will influence KISQALI's market position in the coming years. Additionally, ongoing research and the potential for new indications could further shape KISQALI's growth trajectory.
Table of Contents
1. Report Introduction
2. KISQALI: Novartis
2.1. Product Overview
2.2. Other Development Activities
2.3. Clinical Development
2.4. Clinical Trials Information
2.5. Safety and Efficacy
2.6. Product Profile
2.7. Market Assessment
2.7.1. The 7MM Analysis
2.7.1.1. Cost Assumptions and Rebate
2.7.1.2. Pricing Trends
2.7.1.3. Analogue Assessment
2.7.1.4. Launch Year and Therapy Uptake
2.7.2. The United States Market Analysis
2.7.3. EU4 and the United Kingdom Market Analysis
2.7.3.1. Germany
2.7.3.2. France
2.7.3.3. Italy
2.7.3.4. Spain
2.7.3.5. UK
2.7.4. Japan Market Analysis
2.8. Market Drivers
2.9. Market Barriers
2.10. SWOT Analysis
3. Key Cross of Marketed Competitors of KISQALI
4. Key Cross of Emerging Competitors of KISQALI
Related Reports
CDK4/6 Inhibitor Market
CDK4/6 Inhibitor Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CDK4/6 inhibitor companies, including Pfizer, Prelude Therapeutics, G1 Therapeutics, Pepper Bio, among others.
About DelveInsight
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.
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