Frequently asked questions about KISQALI^® (ribociclib) + AI in stage II/III HR+/HER2- early breast cancer at high risk of recurrence

KISQALI^® (ribociclib), in combination with an aromatase inhibitor (AI), is approved for patients with stage II/III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) at high risk of recurrence. Among these patients, KISQALI is the only cyclin-dependent kinase 4/6 (CDK4/6) inhibitor proven and FDA approved for all node-positive and high-risk node-negative disease.^1,2

View full patient eligibility criteria for KISQALI^® (ribociclib)

FDA, US Food and Drug Administration.

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2− early breast cancer. Ther Adv Med Oncol. 2023;15:1-16. doi:10.1177/17588359231178125

Yes, KISQALI^® (ribociclib), in combination with an aromatase inhibitor (AI), is approved for patients with stage II/III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) at high risk of recurrence, including patients with high-risk node-negative (N0) disease. For these patients, KISQALI is the only proven and FDA-approved cyclin-dependent kinase 4/6 (CDK4/6) inhibitor.^1,2,*

View full patient eligibility criteria for KISQALI^® (ribociclib)

FDA, US Food and Drug Administration.
*In the NATALEE trial, eligible stages and nodal status included anatomic stage group IIB-III, or anatomic stage group IIA that is either node positive, or node negative with histologic grade 3, or histologic grade 2 with Ki-67 ≥20% and/or high risk by gene signature testing.¹

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2− early breast cancer. Ther Adv Med Oncol. 2023;15:1-16. doi:10.1177/17588359231178125

In NATALEE, for patients with stage II/III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC), “high-risk features” were defined for N0 disease as^1,2:

• Tumor size >2 cm and ≤5 cm: G3 or G2 + Ki-67 ≥20% or high genomic risk

• Tumor size >5 cm or tumor of any size with extension to the chest wall and/or skin 

View full patient eligibility criteria for KISQALI^® (ribociclib)

G, grade; N, nodal status.

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2− early breast cancer. Ther Adv Med Oncol. 2023;15:1-16. doi:10.1177/17588359231178125

KISQALI^® (ribociclib) has been proven in the NATALEE trial—NATALEE studied the broadest range of patients of any positive CDK4/6 inhibitor trial in stage II/III HR+/HER2- eBC, including all those with node positive or high-risk node-negative disease (eligible stages and nodal status include: anatomic stage group IIB-III, or anatomic stage group IIA that is either node positive, or node negative with histologic grade 3, or histologic grade 2 with Ki-67 ≥20% and/or high risk by gene signature testing).¹

• NATALEE was a randomized, multicenter, open-label, phase III study of KISQALI, in combination with letrozole or anastrozole (n=2549), vs letrozole or anastrozole (n=2552) for the adjuvant treatment of men and women with stage II/III HR+/HER2- eBC^1,2

• Invasive disease-free survival (iDFS) was the primary end point in NATALEE; distant disease-free survival (DDFS), overall survival (OS), and health-related quality of life (HRQOL) were all secondary end points^1,2

In the 3-year final analysis (median follow-up of 33.3 months) iDFS at 3 years was 90.7% for KISQALI + AI vs 87.6% for AI alone (absolute difference 3.1%). There was a 25.1% relative reduction in the risk of an iDFS event; HR=0.749 (95% CI: 0.628-0.892). In an interim analysis, at a median follow-up of 28 months, a statistically significant reduction in risk was achieved despite the greater challenge of showing clinical benefit in a broad range of patients.^1,3-5

Learn more about how KISQALI^® (ribociclib) has been studied and proven

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390(12):1080-1091. doi:10.1056/NEJMoa2305488 3. Hortobagyi GN, Lacko A, Sohn J, et al. A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: final invasive disease-free survival results from the NATALEE trial. Ann Oncol. 2025;36(2):149-157. doi:10.1016/j.annonc.2024.10.015 4. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2− early breast cancer. Ther Adv Med Oncol. 2023;15:1-16. doi:10.1177/17588359231178125 5. Fasching PA, Stroyakovskiy D, Yardley DA, et al. Adjuvant ribociclib plus nonsteroidal aromatase inhibitor in patients with HR+/HER2− early breast cancer: 4-year outcomes from the NATALEE trial. Presented at: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spain.

Yes, KISQALI^® (ribociclib), in combination with an aromatase inhibitor (AI), can help reduce the risk of recurrence in patients with stage II/III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) at high risk of recurrence. This was demonstrated in the NATALEE trial 3-year final analysis, in which treatment with KISQALI plus AI reduced the risk of recurrence by 25% vs AI alone (invasive disease-free survival [iDFS] at a median follow-up of 33.3 months; HR=0.749 [95% CI: 0.628-0.892]; absolute difference 3.1%). Data from a 5-year follow-up of the NATALEE trial is also available.^1,2

Explore the latest efficacy data for KISQALI^® (ribociclib)

NATALEE was a randomized, multicenter, open-label, phase III study of KISQALI + letrozole or anastrozole (n=2549) vs letrozole or anastrozole (n=2552) for the adjuvant treatment of men and women with stage II/III HR+/HER2- eBC, including all those with node-positive or high-risk node-negative (N0) disease (eligible stages and nodal status include: anatomic stage group IIB-III, or anatomic stage group IIA that is either node positive, or node negative with histologic grade 3, or histologic grade 2 with Ki-67 ≥20% and/or high risk by gene signature testing). Invasive disease-free survival (iDFS) was the primary end point and was defined as the time from randomization to the date of the first event of local invasive breast cancer recurrence, regional invasive recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin), or death (any cause).^1,3-5

HR, hazard ratio. 

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Hortobagyi GN, Lacko A, Sohn J, et al. A phase III trial of adjuvant ribociclib plus endocrine therapy versus endocrine therapy alone in patients with HR-positive/HER2-negative early breast cancer: final invasive disease-free survival results from the NATALEE trial. Ann Oncol. 2025;36(2):149-157. doi:10.1016/j.annonc.2024.10.015 3. Slamon D, Lipatov O, Nowecki Z, et al. Ribociclib plus endocrine therapy in early breast cancer. N Engl J Med. 2024;390(12):1080-1091. doi:10.1056/NEJMoa2305488 4. Slamon DJ, Fasching PA, Hurvitz S, et al. Rationale and trial design of NATALEE: a phase III trial of adjuvant ribociclib + endocrine therapy versus endocrine therapy alone in patients with HR+/HER2− early breast cancer. Ther Adv Med Oncol. 2023;15:1-16. doi:10.1177/17588359231178125 5. Fasching PA, Stroyakovskiy D, Yardley DA, et al. Adjuvant ribociclib plus nonsteroidal aromatase inhibitor in patients with HR+/HER2− early breast cancer: 4-year outcomes from the NATALEE trial. Presented at: ESMO Congress 2024; September 13-17, 2024; Barcelona, Spain. 15. Data on file. NATALEE (LEE011O1). Novartis Pharmaceuticals Corp; 2024.

In the NATALEE trial, the most common adverse reactions (ARs) (occurring in ≥20% of patients treated with KISQALI^® (ribociclib) + aromatase inhibitor [AI]), including laboratory abnormalities, were decrease in lymphocytes, decrease in leukocytes, decrease in neutrophils, decrease in hemoglobin, increase in alanine aminotransferase (ALT), increase in aspartate aminotransferase (AST), infections, increase in creatinine, decrease in platelets, headache, nausea, and fatigue.¹

• The most common grade ≥3 ARs, including laboratory abnormalities, occurring in ≥5% of patients were decrease in neutrophils, decrease in leukocytes, decrease in lymphocytes, increase in ALT, and increase in AST¹

• Fatal ARs occurred in 0.6% of patients who received KISQALI. Fatal ARs in ≥0.1% of patients receiving KISQALI included COVID-19 or COVID-19 pneumonia (0.2%) and pulmonary embolism (0.1%)¹

View the full safety profile for KISQALI^® (ribociclib)

Reference: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp.

In the NATALEE trial, reported rates of diarrhea were low with KISQALI^® (ribociclib)¹:

• 85% of patients (2147/2526) reported no diarrhea

• 14.4% of patients (364/2526) reported grade 1/2 diarrhea

• 0.6% of patients (15/2526) reported grade 3 diarrhea

• 0 patients reported grade 4/5 diarrhea

Diarrhea grades²:

• Grade 1: <4 stools/day over baseline; mild increase in ostomy output

• Grade 2: 4 to 6 stools per day over baseline; moderate increase in ostomy output; limiting instrumental activities of daily living (ADL)

• Grade 3: ≥7 stools per day over baseline; hospitalizations indicated; severe increase in ostomy output; limiting self-care ADL

• Grade 4: Life-threatening; urgent intervention indicated

• Grade 5: Death

View the full safety profile, including rates of diarrhea, for KISQALI^® (ribociclib)

Reference: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. US Department of Health and Human Services. Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. Published November 27, 2017. Accessed June 23, 2026. https://dctd.cancer.gov/research/ctep-trials/for-sites/adverse-events/ctcae-v5-8x11.pdf

In the NATALEE trial, the incidence of QT prolongation observed with KISQALI^® (ribociclib) was low—most cases were moderate and reversible, and the majority occurred within the first 4 weeks of treatment.^1,2

Incidence of QT prolongation in the NATALEE trial was²:

• 4.3%: All grades

• 0.3%: Grades ≥3

Among cases of QT prolongation¹:

• 0.3% had a >500 ms postbaseline QT interval corrected by Fridericia’s formula (QTcF) value

• 2% had a >60 ms increase from baseline in QTcF interval

• There were no reported cases of torsades de pointes

View the full safety profile, including rates of QT prolongation, for KISQALI^® (ribociclib)

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Data on file. CLEE011O12301C (NATALEE) final iDFS analysis CSR. Novartis Pharmaceuticals Corp; 2023.

Baseline assessments—complete blood count (CBC), liver function tests (LFTs), electrolytes, electrocardiograms (ECGs)—are required before initiating treatment with KISQALI (ribociclib). Correct any electrolyte abnormalities prior to treatment. Electrolytes should be checked at Day 1 of cycle 2 and Day 1 of cycles 3-6.¹

After that, CBC and LFT monitoring is performed on Day 14 of Cycle 1, on Days 1 and 14 of Cycle 2, on Day 1 of Cycles 3 through 6, and as clinically indicated. For LFTs, if grade ≥2 abnormalities are noted, more frequent monitoring is recommended. Additional monitoring may be required as clinically indicated.¹

Following the baseline ECG, a second ECG should be performed on Day 14 of Cycle 1, and as clinically indicated. KISQALI should only be initiated in patients with QT interval corrected by Fridericia's formula (QTcF) <450 ms. In cases of QTcF prolongation during therapy, more frequent assessments are recommended. Additional monitoring may be required as clinically indicated.¹

Learn more about the schedule of assessments for KISQALI^® (ribociclib)

Reference: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp.

Yes, support for electrocardiograms (ECGs) is provided through the KISQALI^® (ribociclib) ECG Device Monitoring Program. Health care providers (HCPs) and patients can gain access to the KardiaMobile 6L ECG device so ECG assessments can be completed in seconds at home or in a doctor’s office. There is no direct cost to HCPs or patients for participating in this program. Actual ECG readings take seconds and fit into any office workflow—QT interval corrected by Fridericia's formula (QTcF) results from the ECG device are available instantaneously, with the option for a board-certified cardiologist overread.

Learn more about the ECG device monitoring program for KISQALI^® (ribociclib)

Limitations apply. KISQALI ECG Device Monitoring Program is only permitted to be used for monitoring or evaluating a patient for the current or potential administration of ribociclib. The equipment or services are not permitted to be used for any purpose outside of the scope of the program. You must not bill any entity or person for any equipment or services relating to the provision or interpretation of the ECG. In the event that you fail to abide by the rules of the KISQALI ECG Device Monitoring Program, your participation in the program may be terminated or modified at any time without prior notice, and you may be subject to additional remedies. Additional terms and conditions apply.

Sunshine Act costs may apply.

For additional information, please contact your Novartis Oncology Specialist.

The starting dose for KISQALI^® (ribociclib) is 400 mg orally (two 200-mg tablets), given once daily (3 weeks on, 1 week off) for 3 years, in combination with an aromatase inhibitor (AI), for patients with stage II/III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC).¹

• Review the full Prescribing Information for recommended dosing of selected AI  

• A luteinizing hormone-releasing hormone (LHRH) agonist should be used concomitantly with AI in men and premenopausal women

• Patients should continue treatment for 3 years or until disease recurrence or unacceptable toxicity

• KISQALI can be taken with or without food

• Patients may store KISQALI at room temperature at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F)

• Store in the original blister package in order to protect from moisture

• Starting dose modification for severe renal impairment¹

• The recommended starting dose is 200 mg once daily for patients with severe renal impairment 

View the full dosing guidance for KISQALI^® (ribociclib)

Reference: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp.

Yes, dose adjustments for some adverse reactions (ARs) can be made by reducing the number of KISQALI^® (ribociclib) tablets taken. For patients with stage II/III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC), the starting dose for KISQALI is 400 mg orally (two 200-mg tablets), given once daily (3 weeks on, 1 week off). The dose of KISQALI in eBC may be reduced to one 200-mg oral tablet, once daily, based on individual safety and tolerability. If dose reduction below 200 mg/day is required, treatment with KISQALI should be discontinued. KISQALI dose modification is recommended based on individual safety and tolerability. KISQALI can be taken with or without food.¹

Review the full Prescribing Information for recommended dosing of selected AI. An LHRH agonist should be used concomitantly with AI in men and premenopausal women.

Learn more about dose adjustment for KISQALI^® (ribociclib)

Reference: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp.

Patients may store KISQALI^® (ribociclib) at room temperature at 20°C to 25°C (68°F to 77°F). Excursions are permitted between 15°C and 30°C (59°F and 86°F). KISQALI should be stored in the original blister package in order to protect from moisture.¹

Review full storage and dosing instructions for KISQALI^® (ribociclib)

Reference: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp.

Yes, KISQALI^® (ribociclib) is among the treatments included in national cancer treatment guidelines.¹

Learn more about the national cancer treatment guidelines for KISQALI^® (ribociclib)

Reference: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Breast Cancer V.6.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed July 30, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org.

National Comprehensive Cancer Network® (NCCN®) recommends 3 years of once-daily adjuvant ribociclib (KISQALI^®) as a Category 1 Preferred option in combination with an aromatase inhibitor (AI) for appropriate patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer (eBC) at high risk of recurrence—the only cyclin-dependent kinase 4/6 (CDK4/6) inhibitor to receive this designation for both high-risk node-negative and any node-positive disease, including N1 disease with grade 1 (G1) or grade 2 (G2) and tumor size <5 cm.¹

Ribociclib (KISQALI^®) is approved for use in combination with an AI; node-positive disease excludes patients with microscopic nodal involvement.^1,2
High-risk node-negative disease is defined as either tumor size >5 cm, or if tumor size 2-5 cm, either grade 2 (with high genomic risk or Ki-67 ≥20%), or grade 3.¹
NCCN makes no warranties of any kind whatsoever regarding their content, use, or application and disclaims any responsibility for their application or use in any way.¹
Category 1: Based upon high-level evidence (≥1 randomized phase III trials or high-quality, robust meta-analyses), there is uniform NCCN consensus (≥85% support of the Panel) that the intervention is appropriate.¹

Learn more about the NCCN Guidelines^® for KISQALI^® (ribociclib)

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.6.2026. © National Comprehensive Cancer Network, Inc. 2026. All rights reserved. Accessed July 30, 2026. To view the most recent and complete version of the guideline, go online to NCCN.org. 2. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp.

Yes, Novartis provides a patient support program, called Novartis Patient Support™, that helps eligible patients start, stay and save on KISQALI. Dedicated and personalized services include:

• Insurance support: Help navigating the insurance process, including benefits verification and support with the prior authorization (PA) and appeals processes

• Financial support: Assistance with connecting patients to relevant savings options

• Electrocardiogram (ECG) testing support: Guidance on workflow and options for testing 

• Ongoing support: Dedicated assistance from a Novartis Patient Support Team member and educational resources to help patients get started on treatment and guide them every step of the way 

Explore the Novartis Patient Support program for KISQALI^® (ribociclib)

Yes, for most patients with prescription drug insurance coverage, all or nearly all of the cost of KISQALI^® (ribociclib) is covered, and prior authorizations (PAs) are approved within 1 day.

• For Medicare members, nearly 90% of KISQALI out-of-pocket costs were between $0 and $20 per month¹

• For patients with commercial insurance, approximately 80% of KISQALI out-of-pocket costs were between $0 and $50 per month¹

• More than 9 out of 10 patients have preferred formulary coverage for KISQALI^2,*

• More than 90% of KISQALI PAs are approved in less than 24 hours³

Novartis does not guarantee payment or coverage for any product or service. Actual coverage and reimbursement decisions are made by individual payers following receipt of claims. Coverage is subject to change by the relevant payer.

Look up the local insurance coverage for KISQALI^® (ribociclib)

*>98% unrestricted coverage in Commercial and Medicare, based on MMIT data, as of June 2026.

References: 1. Data on file. Kisqali IQVIA data through November 2025. Novartis Pharmaceuticals Corp; 2026. 2. Data on file. Kisqali MMIT data June 2026. Novartis Pharmaceuticals Corp; 2026. 3. Data on file. Kisqali CMM AMP data review February 2026. Novartis Pharmaceuticals Corp; 2026.