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AboutAboutIBRANCE experienceMechanism of actionDosing & MonitoringDosing & MonitoringDosing and administrationMonitoringRecommended dose modifications for IBRANCEWhat you need to know about IBRANCE tabletsEfficacyEfficacyIBRANCE + aromatase inhibitorPrimary endpointSecondary endpointsUpdated analysesSubgroup analysesIBRANCE + fulvestrantPrimary endpointSecondary endpointsUpdated analysesSubgroup analysesSafety DataSafety DataIBRANCE + aromatase inhibitorAdverse reactionsDiscontinuations and dose reductionsNeutropenia and lab abnormalitiesWarnings and PrecautionsIBRANCE + fulvestrantAdverse reactionsDiscontinuations and dose reductionsNeutropenia and lab abnormalitiesWarnings and PrecautionsReal-World Evidence​​​​​​​Real-World EvidenceIntroductionClinical trial summaryReal-world study designReal-world study patient characteristicsReal-world effectivenessLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkSupport & OrderSupport &
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Prescribing Information for CapsulesPrescribing Information for Tablets Indications Patient Site
Real-World Evidence

Real-world study design

Real-world evidence complements data from randomized clinical trials. It is important to understand both the randomized clinical trial results and the limitations of this observational retrospective real-world study.

Expand here to view
  • Review results from PALOMA-2, the randomized clinical trial that evaluated IBRANCE + letrozole in postmenopausal women with estrogen receptor-positive (ER+)/HER2- mBC and no prior treatment in the metastatic setting1
  • Understand the limitations of this observational retrospective real-world study:
    • This study is a retrospective database study of electronic health records, which may have missing or erroneous data entry and cannot determine causal relationship2 
    • Disease progression was based on the treating physician’s clinical assessment or interpretation of radiographic or pathologic results rather than standard criteria (e.g., Response Evaluation Criteria in Solid Tumors)2
    • While stabilized inverse probability treatment weighting and propensity score matching were used to balance baseline and clinical patient characteristics, unobserved variables cannot be fully addressed through these methods2
    • Findings presented here may not be generalizable to patient populations not represented in the Flatiron Database2
    • Safety data were not collected as part of the study
P-REALITY X: Palbociclib Real-world First-line Comparative Effectiveness Study Extended2,3

Objective

  • To determine real-world effectiveness of first-line use of IBRANCE + letrozole vs letrozole alone in a cohort of women with HR+/HER2- mBC treated in routine clinical practice from across the United States

Study design: Observational, retrospective analysis of electronic health records (EHRs) from the Flatiron Health Analysis Database to compare effectiveness of IBRANCE + aromatase inhibitor (AI) vs AI alone in postmenopausal women or men receiving first-line treatment for HR+/HER2- mBC.

  • The Flatiron Health Analytic Database is a longitudinal database that includes structured and unstructured EHRs from >280 cancer clinics, including approximately 800 sites of care, and represents >3 million patients with cancer actively being treated in the United States

ReferencesOS was defined as the time in months from the start of treatment with palbociclib + an AI or with an AI alone to death from any cause.2rwPFS was defined as the number of months from the start of treatment with palbociclib + an AI or with an AI alone to the date of the first documentation of real-world progressive disease or death due to any cause, whichever occurred first.2

Study limitations

  • This study is a retrospective database study of EHRs, which may have missing or erroneous data entry and cannot determine causal relationship2

  • Disease progression was based on the treating physician’s clinical assessment or interpretation of radiographic or pathologic results rather than standard criteria (e.g., Response Evaluation Criteria in Solid Tumors)2

  • While sIPTW and PSM were used to balance baseline and clinical patient characteristics, unobserved variables cannot be fully addressed through these methods2

  • Findings presented here may not be generalizable to patient populations not represented in the Flatiron Database2

  • Safety data were not collected as part of the study

Observational retrospective analyses are not intended for direct comparison with clinical trials.

Review the randomized clinical trial information Take another look Loading NEXT: Real-world study patient characteristics See the data LoadingReferences:Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.Rugo HS, Brufsky A, Liu X, et al. Real-world study of overall survival with palbociclib plus aromatase inhibitor in HR+/HER2– metastatic breast cancer. NPJ Breast Cancer. 2022;8(1):114. doi:10.1038/s41523-022-00479-xDeMichele A, Cristofanilli M, Brufsky A, et al. Comparative effectiveness of first-line palbociclib plus letrozole versus letrozole alone for HR+/HER2- metastatic breast cancer in US real-world clinical practice. Breast Cancer Res. 2021;23(1):37. Published online March 24, 2021. doi:10.1186/s13058-021-01409-8To view a copy of the license for Rugo HS, Brufsky A, Liu X, et al (NPJ Breast Cancer. 2022;8(1):114), please visit https://creativecommons.org/licenses/by/4.0/
Real-World Evidence

Access the publication.

The FDA-approved Prescribing Information for IBRANCE includes data from the PALOMA trials. However, some data reported in this publication may be different from, or are not included in, the IBRANCE Prescribing Information. Please review results from PALOMA-2 provided on this page. The study met its primary endpoint of progression-free survival but did not meet the secondary endpoint of overall survival.

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INDICATIONS IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:
  • an aromatase inhibitor as initial endocrine-based therapy, or
  • fulvestrant in patients with disease progression following endocrine therapy
Important Safety Information

Neutropenia was the most frequently reported adverse reaction in PALOMA-2 (80%) and PALOMA-3 (83%). In PALOMA-2, Grade 3 (56%) or 4 (10%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (55%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE across PALOMA-2 and PALOMA-3. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever.

Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of first 2 cycles and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia.
 

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with CDK4/6 inhibitors, including IBRANCE when taken in combination with endocrine therapy. Across clinical trials (PALOMA-1, PALOMA-2, PALOMA-3), 1.0% of IBRANCE-treated patients had ILD/pneumonitis of any grade, 0.1% had Grade 3 or 4, and no fatal cases were reported. Additional cases of ILD/pneumonitis have been observed in the post-marketing setting, with fatalities reported.
 

Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis (e.g., hypoxia, cough, dyspnea). In patients who have new or worsening respiratory symptoms and are suspected to have developed pneumonitis, interrupt IBRANCE immediately and evaluate the patient. Permanently discontinue IBRANCE in patients with severe ILD or pneumonitis.
 

Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients to consider sperm preservation before taking IBRANCE. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants. 
 

The most common adverse reactions (≥10%) of any grade reported in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (80% vs 6%), infections (60% vs 42%), leukopenia (39% vs 2%), fatigue (37% vs 28%), nausea (35% vs 26%), alopecia (33% vs 16%), stomatitis (30% vs 14%), diarrhea (26% vs 19%), anemia (24% vs 9%), rash (18% vs 12%), asthenia (17% vs 12%), thrombocytopenia (16% vs 1%), vomiting (16% vs 17%), decreased appetite (15% vs 9%), dry skin (12% vs 6%), pyrexia (12% vs 9%), and dysgeusia (10% vs 5%).
 

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were neutropenia (66% vs 2%), leukopenia (25% vs 0%), infections (7% vs 3%), and anemia (5% vs 2%).
 

Lab abnormalities of any grade occurring in PALOMA-2 for IBRANCE plus letrozole vs placebo plus letrozole were decreased WBC (97% vs 25%), decreased neutrophils (95% vs 20%), anemia (78% vs 42%), decreased platelets (63% vs 14%), increased aspartate aminotransferase (52% vs 34%), and increased alanine aminotransferase (43% vs 30%). 

 

The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%).
 

The most frequently reported Grade ≥3 adverse reactions (≥5%) in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were neutropenia (66% vs 1%) and leukopenia (31% vs 2%). 
 

Lab abnormalities of any grade occurring in PALOMA-3 for IBRANCE plus fulvestrant vs placebo plus fulvestrant were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), decreased platelets (62% vs 10%), increased aspartate aminotransferase (43% vs 48%), and increased alanine aminotransferase (36% vs 34%). 
 

Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure.
 

For patients with severe hepatic impairment (Child-Pugh class C), the recommended dose of IBRANCE is 75 mg. The pharmacokinetics of IBRANCE have not been studied in patients requiring hemodialysis

Please see full Prescribing Information for IBRANCE capsules and tablets.

INDICATIONS IBRANCE® (palbociclib) 125 mg capsules and tablets are indicated for the treatment of adult patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (mBC) in combination with:
  • an aromatase inhibitor as initial endocrine-based therapy, or
  •  
  • fulvestrant in patients with disease progression following endocrine therapy
  •