Frequently asked questions about KISQALI^® (ribociclib) + AI or fulvestrant in HR+/HER2- metastatic breast cancer

KISQALI^® (ribociclib) is approved for premenopausal and postmenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC), in combination with¹: 

• an aromatase inhibitor (AI) as initial endocrine-based therapy; or 

• fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy (ET)

Discover more about KISQALI^® (ribociclib) for the treatment of metastatic breast cancer

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

Yes, KISQALI^® (ribociclib) can be used in combination with fulvestrant after disease progression on endocrine therapy (ET) in appropriate patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). This use is supported by clinical trial data, including from MONALEESA-3, which studied KISQALI + fulvestrant for first- and second-line (1L and 2L) postmenopausal patients with HR+/HER2- mBC who received no or only 1 line of prior ET for advanced disease.¹

Explore KISQALI^® (ribociclib) data from the MONALEESA-3 trial

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

Yes, KISQALI^® (ribociclib) can be used in appropriate patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC), including patients with visceral disease. KISQALI was assessed in first-line (1L) patients with visceral metastases in an exploratory, pooled subgroup analysis of the 3 phase III MONALEESA trials. The results of this trial are exploratory and hypothesis-generating; as such, there was no statistical procedure controlling for type 1 error. Additionally, KISQALI was evaluated against combination chemotherapy in the phase II RIGHT Choice trial for patients with aggressive disease. Due to the nature of the study, results should be interpreted with caution. These results from a subgroup analysis of patients with aggressive disease who did not have visceral crisis are exploratory and hypothesis-generating; as such, there was no statistical procedure controlling for type 1 error. In the 3 phase III MONALEESA clinical trials, ≥50% of patients studied had visceral metastases.^1,2

Explore KISQALI^® (ribociclib) data for patients with visceral disease

References: 1. Yardley DA, Yap YS, Azim HA, et al. Pooled exploratory analysis of survival in patients with HR+/HER2− advanced breast cancer and visceral metastases treated with ribociclib + endocrine therapy in the MONALEESA trials. Poster presented at: ESMO Congress 2022; September 9-13, 2022; Paris, France. Poster 205P. 2. Lu Y-S, Mahidin EIBM, Azim H, et al. Final results of RIGHT Choice: ribociclib plus endocrine therapy versus combination chemotherapy in premenopausal women with clinically aggressive hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. J Clin Oncol. 2024;42(23):2812-2821. doi:10.1200/JCO.24.00144

Yes, KISQALI^® (ribociclib) is the only cyclin-dependent kinase 4/6 (CDK4/6) inhibitor to achieve statistically significant overall survival (OS) in first-line (1L) postmenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC), in combination with an aromatase inhibitor (AI). This OS benefit was demonstrated in the phase III MONALEESA‑2 clinical trial: in the prespecified final OS analysis, at a median follow-up of 80 months, median overall survival (mOS) was 63.9 months with KISQALI + letrozole (95% CI: 52.4-71.0) vs 51.4 months with placebo + letrozole (95% CI: 47.2-59.7); HR=0.765 (95% CI: 0.628-0.932); P=0.004.^1,2

Explore efficacy data for KISQALI^® (ribociclib) from the MONALEESA-2 trial in metastatic breast cancer 

MONALEESA-2 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + letrozole (n=334) vs placebo + letrozole (n=334) in postmenopausal patients with HR+/HER2- mBC who received no prior therapy for advanced disease. OS was a secondary end point; progression-free survival (PFS) was the primary end point.^1,2

HR, hazard ratio.

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386(10):942-950. doi:10.1056/NEJMoa2114663

In the MONALEESA-2 trial, the most common adverse reactions (ARs) (occurring in ≥20% of postmenopausal patients treated with KISQALI^® [ribociclib] + letrozole and ≥2% higher than placebo), including laboratory abnormalities, were decrease in neutrophils, decrease in leukocytes, decrease in hemoglobin, nausea, decrease in lymphocytes, increase in alanine aminotransferase (ALT), increase in aspartate aminotransferase (AST), fatigue, diarrhea, alopecia, vomiting, decrease in platelets, constipation, headache, and back pain. These safety data were evaluated for 668 postmenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) who were treated with KISQALI + letrozole or placebo + letrozole in MONALEESA-2.¹

• Dose reductions of KISQALI due to an adverse reaction occurred in 45% of patients receiving KISQALI + letrozole¹

• Permanent discontinuation of both KISQALI and letrozole due to an adverse reaction occurred in 7% of patients¹

• Fatal ARs occurred in 1.8% of patients who received KISQALI. Fatal ARs in ≥0.1% of patients receiving KISQALI included acute respiratory failure (0.6%), acute myocardial infarction, sudden death (with grade 3 hypokalemia and grade 2 QT prolongation), unknown cause, and pneumonia (0.3% each)¹

View the full safety profile for KISQALI^® (ribociclib) from the MONALEESA-2 trial in metastatic breast cancer

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

Yes, KISQALI^® (ribociclib), in combination with fulvestrant, significantly improved overall survival (OS) in first‑ and second-line (1L/2L) postmenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). This was demonstrated in the phase III MONALEESA‑3 clinical trial: in the prespecified OS analysis of the intent-to-treat population (ITT), at a median follow-up of 39 months, median overall survival (mOS) was not reached with KISQALI + fulvestrant (95% CI: 42.5-NR) vs 40 months with placebo + fulvestrant (95% CI: 37.0-NR); HR=0.724 (95% CI: 0.568-0.924); P=0.00455. OS data for the first-line subgroup of patients are also available.^1-3

Explore efficacy data for KISQALI^® (ribociclib) from the MONALEESA-3 trial in metastatic breast cancer 

MONALEESA-3 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2- mBC who received no or only 1 line of prior endocrine therapy (ET) for advanced disease. OS was a secondary end point; progression-free survival (PFS) was the primary end point.^1,2

HR, hazard ratio; NR, not reached.

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. 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;36(24):2465-2472. doi:10.1200/JCO.2018.78.9909 3. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514-524. doi:10.1056/NEJMoa1911149

In the MONALEESA-3 trial, the most common adverse reactions (ARs) (occurring in ≥20% of postmenopausal patients treated with KISQALI^® [ribociclib] + fulvestrant and ≥2% higher than placebo), including laboratory abnormalities, were decrease in leukocytes, decrease in neutrophils, decrease in lymphocytes, increase in creatinine, decrease in hemoglobin, increase in gamma-glutamyl transferase (GGT), increase in aspartate aminotransferase (AST), nausea, increase in alanine aminotransferase (ALT), infections, decrease in platelets, diarrhea, vomiting, constipation, decrease in glucose serum, cough, rash, and pruritus. These safety data were evaluated for 724 postmenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) who were treated with KISQALI + fulvestrant or placebo + fulvestrant in MONALEESA-3.¹

• Dose reductions of KISQALI due to an adverse reaction occurred in 32% of patients receiving KISQALI + fulvestrant¹

• Permanent discontinuation of both KISQALI and fulvestrant due to an adverse reaction occurred in 8% of patients¹

• Fatal ARs occurred in 1.2% of patients who received KISQALI. Fatal ARs in ≥0.1% of patients receiving KISQALI included cardiac failure, ventricular arrhythmia, pneumonia, acute respiratory distress, pulmonary embolism, and hemorrhagic shock (0.2% each)¹

View the full safety profile for KISQALI^® (ribociclib) from the MONALEESA-3 trial in metastatic breast cancer

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

Yes, KISQALI^® (ribociclib), in combination with a nonsteroidal aromatase inhibitor (NSAI) and goserelin, improved overall survival (OS) in first-line (1L) premenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC). This benefit was demonstrated in the phase III MONALEESA‑7 clinical trial. KISQALI is the only cyclin-dependent kinase 4/6 (CDK4/6) inhibitor with a trial dedicated to premenopausal patients with HR+/HER2- mBC.^1-3

The intent-to-treat (ITT) population of the MONALEESA-7 trial included 672 patients treated with KISQALI (n=335) or placebo (n=337), in combination with endocrine therapy (ET) (either NSAI or tamoxifen) + goserelin. In the subgroup of patients who received tamoxifen, an increased risk for QT prolongation was observed. KISQALI is not indicated for concomitant use with tamoxifen. Efficacy results are from a prespecified analysis of 495 patients who received KISQALI (n=248) or placebo (n=247) with NSAI + goserelin. In the prespecified OS analysis, at a median follow-up of 35 months, median overall survival (mOS) was not reached with KISQALI + NSAI + goserelin (95% CI: NR-NR) vs 40.7 months with placebo + NSAI + goserelin (95% CI: 37.4-NR); HR=0.699 (95% CI: 0.501-0.976). Statistical significance was established for the ITT population; HR=0.71 (95% CI: 0.54-0.95); P=0.00973. OS data from a follow-up analysis of the NSAI subgroup are also available.^1,2,4

Explore efficacy data for KISQALI^® (ribociclib) from the MONALEESA-7 trial in metastatic breast cancer

MONALEESA-7 was a randomized, double-blind, placebo-controlled, phase III study in premenopausal patients with HR+/HER2- mBC who received no prior ET for advanced disease. OS was a secondary end point; progression-free survival (PFS) was the primary end point.^1,4

HR, hazard ratio; NR, not reached.

References: 1. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 2. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316. doi:10.1056/NEJMoa1903765 3. Lu Y-S, Im S-A, Colleoni M, et al. Updated overall survival of ribociclib plus endocrine therapy versus endocrine therapy alone in pre- and perimenopausal patients with HR+/HER2- advanced breast cancer in MONALEESA-7: a phase III randomized clinical trial. Clin Cancer Res. 2022;28(5):851-859. doi:10.1158/1078-0432.CCR-21-3032 4. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-915. doi:10.1016/S1470-2045(18)30292-4

In the MONALEESA-7 trial, the most common adverse reactions (ARs) (occurring in ≥20% of premenopausal patients treated with KISQALI^® [ribociclib] + a nonsteroidal aromatase inhibitor [NSAI] + goserelin and ≥2% higher than placebo), including laboratory abnormalities, were decrease in leukocytes, decrease in neutrophils, decrease in hemoglobin, decrease in lymphocytes, increase in gamma-glutamyl transferase (GGT), increase in aspartate aminotransferase (AST), infections, arthralgia, increase in alanine aminotransferase (ALT), nausea, decrease in platelets, and alopecia. These safety data were evaluated for 495 premenopausal women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) who were treated with KISQALI + NSAI + goserelin or placebo + NSAI + goserelin in MONALEESA-7.¹

• Dose reductions of KISQALI due to an adverse reaction occurred in 33% of patients receiving KISQALI + NSAI + goserelin¹

• Permanent discontinuation of KISQALI + NSAI + goserelin due to an adverse reaction occurred in 3% of patients¹

View the full safety profile for KISQALI^® (ribociclib) from the MONALEESA-7 trial in metastatic breast cancer

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

Baseline assessments—complete blood count (CBC), liver function tests (LFTs), electrolytes, electrocardiagrams (ECGs)—are required before initiating treatment with KISQALI^® (ribociclib). Correct any electrolyte abnormalities prior to treatment.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.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 case of QTcF prolongation during therapy, more frequent assessments are recommended.¹

Additional monitoring may be required as clinically indicated.¹

Learn more about the schedule of assessments for KISQALI^® (ribociclib) in metastatic breast cancer

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) in metastatic breast cancer

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.

There was a low incidence of QT prolongation with KISQALI^® (ribociclib) across the 3 phase III MONALEESA clinical trials. Most cases of QT prolongation were moderate in nature.^1-4

Data are from a pooled analysis of 1054 premenopausal and postmenopausal patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) who were treated with KISQALI + an aromatase inhibitor (AI) or fulvestrant in the first- or second-line (1L/2L) across the MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials.⁴

In the pooled analysis⁴:

• 1.4% of patients had a >500 ms postbaseline QTcF value 

• 6% experienced a >60 ms increase from baseline in QTcF interval 

• There were no reported cases of torsades de pointes 

In each MONALEESA trial: 

• MONALEESA-2 (KISQALI + AI in 1L postmenopausal patients): <1% of patients had a >500 ms postbaseline QTcF value, and 3% experienced a >60 ms increase from baseline in QTcF interval. There was 1 (0.3%) sudden death in a patient with grade 3 hypokalemia and grade 2 QT prolongation^1,4

• MONALEESA-3 (KISQALI + fulvestrant in 1L/2L postmenopausal patients): 2% of patients had a >500 ms postbaseline QTcF value, and 7% experienced a >60 ms increase from baseline in QTcF interval. No cases of sudden death were reported²

• MONALEESA-7 (KISQALI + AI in 1L premenopausal patients): The number of patients who had a >500 ms postbaseline QTcF value was not reached, and 7% experienced a >60 ms increase from baseline in QTcF interval. No cases of sudden death were reported³

KISQALI has been shown to prolong the QT interval in a concentration-dependent manner. Based on the observed QT prolongation during treatment, KISQALI may require dose interruption, reduction, or discontinuation. In case of QTcF prolongation at any given time during treatment, more frequent electrocardiogram (ECG) monitoring is recommended. In the subgroup of patients who received tamoxifen, an increased risk for QT prolongation was observed. KISQALI is not indicated for concomitant use with tamoxifen.⁴

Learn more about ECG assessments for KISQALI^® (ribociclib) and rates of QT prolongation in metastatic breast cancer

References: 1. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018;29(7):1541-1547. doi:10.1093/annonc/mdy155 2. 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;36(24):2465-2472. doi:10.1200/JCO.2018.78.9909 3. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-915. doi:10.1016/S1470-2045(18)30292-4 4. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp.

In metastatic breast cancer (mBC), the starting dose for KISQALI^® (ribociclib) is 600 mg (3 x 200-mg tablets) orally, once daily (3 weeks on, 1 week off) with either an aromatase inhibitor (AI) or fulvestrant.¹

• When combined with AI: AI should be taken once daily (continuously). In men and premenopausal women, a luteinizing hormone-releasing hormone (LHRH) agonist should be administered according to current clinical practice guidelines. Please refer to the full Prescribing Information for the recommended dose of the chosen AI¹

• When combined with fulvestrant: fulvestrant 500 mg should be administered intramuscularly on Days 1, 15, and 29, and once monthly thereafter; in men and premenopausal women, an LHRH agonist should also be administered according to current clinical practice guidelines. Please refer to the full Prescribing Information for fulvestrant¹

• KISQALI can be taken with or without food¹

• Patients should continue treatment until disease progression or unacceptable toxicity¹

• 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)¹

• Store in the original blister package in order to protect from moisture¹ 

• Please refer to the full Prescribing Information for fulvestrant.

• Please refer to the full Prescribing Information for the recommended dose of the chosen AI.

Starting dose modifications for hepatic and severe renal impairment¹

The recommended starting dose is 400 mg once daily for patients with moderate or severe (Child-Pugh class B or C) hepatic impairment.

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

View the full dosing guidance for KISQALI^® (ribociclib) in metastatic breast cancer

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

For patients with HR+/HER2- mBC, KISQALI^® (ribociclib) is given as 600 mg (3 x 200-mg tablets) orally, once daily (3 weeks on, 1 week off) with either AI or fulvestrant¹

• AI should be taken once daily (continuously); in men and premenopausal women, an LHRH agonist should be administered according to current clinical practice guidelines; or

• Fulvestrant 500 mg should be administered intramuscularly on Days 1, 15, and 29, and once monthly thereafter; in men and premenopausal women, an LHRH agonist should also be administered according to current clinical practice guidelines

Dose adjustments of KISQALI for adverse reactions should be made in a stepwise order by reducing the number of tablets taken. The dose of KISQALI in mBC may be reduced to two 200-mg oral tablets (400 mg), or 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 can be taken with or without food.¹

Learn more about dose adjustment for KISQALI^® (ribociclib) in metastatic breast cancer

LHRH, luteinizing hormone-releasing hormone.

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

Across the 3 phase III MONALEESA clinical trials, overall survival (OS) was maintained for patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) who required dose reduction of KISQALI. These data are from a time-varying Cox regression analysis of OS by dose reduction. Results are based on a post hoc analysis; efficacy in the placebo comparator arms was not assessed and should be interpreted with caution^1-5:

• In the MONALEESA-2 trial: 62.6% of patients (209/334) had ≥1 dose reduction. Median overall survival (mOS) was 66.0 months for patients with ≥1 dose reduction (95% CI: 57.6-75.7) vs 60.6 months for patients without dose reductions (95% CI: 42.5-79.2); HR=0.87 (95% CI: 0.65-1.18)^1,2

• In the MONALEESA-3 trial: 40.7% of patients (197/484) had ≥1 dose reduction. mOS was not reached for patients with ≥1 dose reduction (95% CI: 43-NR) vs not reached for patients without dose reductions (95% CI: 41.1-NR); HR=0.88 (95% CI: 0.64-1.21)^3,4

• In the MONALEESA-7 trial: 40.7% of patients (101/248) had ≥1 dose reduction. mOS was not reached for patients with ≥1 dose reduction (95% CI: NR-NR) vs not reached for patients without dose reductions (95% CI: NR-NR); HR=0.79 (95% CI: 0.46-1.36)^3,5

Explore more of the data for KISQALI^® (ribociclib) efficacy in patients requiring dose reductions

MONALEESA-2 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + letrozole (n=334) vs placebo + letrozole (n=334) in postmenopausal patients with HR+/HER2- mBC who received no prior therapy for advanced disease. OS was a secondary end point; progression-free survival (PFS) was the primary end point. At a median follow-up of 80 months, mOS was 63.9 months with KISQALI + letrozole (95% CI: 52.4-71.0) vs 51.4 months with placebo + letrozole (95% CI: 47.2-59.7); HR=0.765 (95% CI: 0.628-0.932); P=0.004.^6,7

MONALEESA-3 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + fulvestrant (n=484) vs placebo + fulvestrant (n=242) in postmenopausal patients with HR+/HER2- mBC who received no or only 1 line of prior endocrine therapy (ET) for advanced disease. OS was a secondary end point; PFS was the primary end point. Statistical significance was established for the intent-to-treat (ITT) population in the prespecified OS analysis at a median follow-up of 39 months: mOS was not reached with KISQALI + fulvestrant (95% CI: 42.5-NR) vs 40 months with placebo + fulvestrant (95% CI: 37.0-NR); HR=0.724 (95% CI: 0.568-0.924); P=0.00455.^6,8,9

MONALEESA-7 was a randomized, double-blind, placebo-controlled, phase III study of KISQALI + ET (a nonsteroidal aromatase inhibitor [NSAI] or tamoxifen) + goserelin (n=335) vs placebo + ET (NSAI or tamoxifen) + goserelin (n=337) (ITT) in premenopausal patients with HR+/HER2- mBC who received no prior ET for advanced disease. KISQALI is not indicated for concomitant use with tamoxifen. Efficacy results are from a prespecified subgroup analysis of 495 patients who received KISQALI (n=248) or placebo (n=247) with an NSAI + goserelin. OS was a secondary end point; PFS was the primary end point. In the prespecified OS analysis at a median follow-up of 35 months, mOS was not reached with KISQALI + NSAI + goserelin (95% CI: NR-NR) vs 40.7 months with placebo + NSAI + goserelin (95% CI: 37.4-NR); HR=0.699 (95% CI: 0.501-0.976). Statistical significance was established for overall survival in the ITT population; HR=0.71 (95% CI: 0.54-0.95); P=0.00973.^6,10,11

HR, hazard ratio; NR, not reached.

References: 1. Data on file. CLEE011A2301 additional analysis. Novartis Pharmaceuticals Corp; 2021. 2. Data on file. M2 OS by dose reduction. Novartis Pharmaceuticals Corp; 2021. 3. Data on file. OS by dose reduction poster. Novartis Pharmaceuticals Corp; 2020. 4. Data on file. CLEE011F2301 additional analysis. Novartis Pharmaceuticals Corp; 2020. 5. Data on file. CLEE011E2301 additional analysis. Novartis Pharmaceuticals Corp; 2020. 6. Kisqali. Prescribing information. Novartis Pharmaceuticals Corp. 7. Hortobagyi GN, Stemmer SM, Burris HA, et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N Engl J Med. 2022;386(10):942-950. doi:10.1056/NEJMoa2114663 8. 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;36(24):2465-2472. doi:10.1200/JCO.2018.78.9909 9. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514-524. doi:10.1056/NEJMoa1911149 10. Tripathy D, Im S-A, Colleoni M, et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018;19(7):904-915. doi:10.1016/S1470-2045(18)30292-4 11. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316. doi:10.1056/NEJMoa1903765

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) in metastatic breast cancer

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®) differentiates ribociclib (KISQALI®) as the only Category 1 Preferred first-line (1L) treatment option in combination with an aromatase inhibitor (AI) for appropriate patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC).¹

There is controversy on the choice of cyclin-dependent kinase 4/6 (CDK4/6) inhibitor as there are no head-to-head comparisons between the agents and there are some differences in the study populations in the phase III randomized studies.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)

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.

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 hours⁴

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) in metastatic breast cancer

* >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.