KISQALI Achieves Significant Market Growth, Strengthening Its Position in Breast Cancer and CDK4/6 Inhibitors Segment | DelveInsight

KISQALI is a promising CDK4/6 inhibitor used in combination with aromatase inhibitors for the treatment of HR-positive, HER2-negative breast cancer. Its market potential remains strong, driven by its efficacy in prolonging progression-free survival in early and metastatic stages of the disease. With a growing demand for targeted therapies and increasing patient awareness, KISQALI's market is expected to expand further.
DelveInsight's "KISQALI Market Size, Forecast, and Market Insight Report [https://www.delveinsight.com/report-store/kisqali-ribociclib-drug-insight-market-forecast?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr]" 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

Learn more about KISQALI projected market size for breast cancer @ KISQALI Sales [http://delveinsight.com/sample-request/kisqali-ribociclib-drug-insight-market-forecast?utm_source=cision&utm_medium=pressrelease&utm_campaign=spr]

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

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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



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