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AboutAboutIBRANCE experienceMechanism of actionDosing & MonitoringDosing & MonitoringDosing and administrationMonitoringRecommended dose modifications for IBRANCEWhat you need to know about IBRANCE tabletsClinical Trial DataClinical Trial DataIBR + AI Efficacy & SafetyIBR + AI Additional AnalysesIBR + Fulvestrant Efficacy & SafetyIBR + Fulvestrant Additional AnalysesReal-World Evidence​​​​​​​Real-World EvidenceIntroductionRandomized controlled trialReal-world study designReal-world study patient characteristicsReal-world effectiveness dataLabelLinkLinkLinkLinkLabelLinkLinkLinkLinkVideosPatient SupportPatient SupportMaterialsCoverage and accessPersonalized patient support
Prescribing Information for CapsulesPrescribing Information for Tablets Indications Patient Site
Clinical Trial DataIBR + AI 

Efficacy & SafetyIBR + AI 

Additional AnalysesIBR + Fulvestrant
​​​​​​Efficacy & SafetyIBR + Fulvestrant
Additional AnalysesPrimary endpoint

PALOMA-2: IBRANCE + aromatase inhibitor

In a 2:1 randomized, double-blind, Phase 3 trial of postmenopausal women receiving first-line treatment for ER+/HER2- mBC (N=666)1*

IBRANCE + letrozole delivered more than 2 years of mPFS in first line†
  • Number of PFS events: 194 (43.7%) with IBRANCE + letrozole vs 137 (61.7%) with  placebo + letrozole
CI=confidence interval; ER=estrogen receptor; HR=hazard ratio; LET=letrozole; mPFS=median progression-free survival; NE=not estimable; PFS=progression-free survival; PLB=placebo.PALOMA-2 was a 2:1 randomized, double-blind, Phase 3 trial that studied IBRANCE 125 mg PO once daily taken 3 weeks on, 1 week off + letrozole 2.5 mg PO once daily vs placebo + letrozole in postmenopausal women with ER+/HER2- mBC with no prior treatment in the metastatic setting.1Unless otherwise stated, PALOMA-2 data are based on the February 2016 data cut (final prespecified analysis).1
IBRANCE + letrozole as initial mBC therapy delays the need for later lines of treatment, including hormonal agents and chemotherapies2
References:​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, Finn RS, Diéras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719-729.Secondary endpointsPALOMA-2: IBRANCE + aromatase inhibitorSelect secondary endpoints1,2

In a 2:1 randomized, double-blind, Phase 3 trial of postmenopausal women receiving first-line treatment for ER+/HER2- mBC (N=666)1*

  • Objective response rate (ORR)†: 55.3% (95% CI: 49.9-60.7) of patients with measurable disease achieved an objective response with IBRANCE + letrozole vs 44.4% (95% CI: 36.9-52.2) with placebo + letrozole (IBRANCE + letrozole n=338; placebo + letrozole n=171)
  • Overall survival (OS)‡: A final OS analysis was conducted with 435 events (~65% of trial population) having occurred
OS was not statistically significantMedian OS was 53.8 months (95% CI: 49.8-59.2) with IBRANCE + letrozole vs 49.8 months (95% CI: 42.3-56.4) with placebo + letrozole (HR=0.92 [95% CI: 0.76-1.12]; P=0.2087)PALOMA-2 was a 2:1 randomized, double-blind, Phase 3 trial that studied IBRANCE 125 mg PO once daily taken 3 weeks on, 1 week off + letrozole 2.5 mg PO once daily vs placebo + letrozole in postmenopausal women with ER+/HER2- mBC with no prior treatment in the metastatic setting.1ORR was defined as the number (%) of patients with confirmed complete response or partial response.1November 2021 data cut.2References:Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936. doi:10.1056/NEJMoa1607303Data on file. Pfizer Inc., New York, NY.Adverse reactionsPALOMA-2: IBRANCE + aromatase inhibitorAdverse reactions (≥10%) reported in PALOMA-2

Unless otherwise stated, PALOMA-2 data are based on the February 2016 data cut (final prespecified analysis).1

N/A=not applicable.Grading according to Common Terminology Criteria for Adverse Events (CTCAE) 4.0.Infections include all reported preferred terms (PTs) that are part of the System Organ Class Infections and infestations.Most common infections (≥1%) include: nasopharyngitis, upper respiratory tract infection, urinary tract infection, oral herpes, sinusitis, rhinitis, bronchitis, influenza, pneumonia, gastroenteritis, conjunctivitis, herpes zoster, pharyngitis, cellulitis, cystitis, lower respiratory tract infection, tooth infection, gingivitis, skin infection, gastroenteritis viral, respiratory tract infection, respiratory tract infection viral, and folliculitis.Stomatitis includes: aphthous stomatitis, cheilitis, glossitis, glossodynia, mouth ulceration, mucosal inflammation, oral pain, oral discomfort, oropharyngeal pain, and stomatitis.Grade 1 events – 30%; Grade 2 events – 3%.Grade 1 events – 15%; Grade 2 events – 1%.Rash includes the following PTs: rash, rash maculo-papular, rash pruritic, rash erythematous, rash papular, dermatitis, dermatitis acneiform, and toxic skin eruption.Selected adverse events (AEs) reported in an updated non-prespecified analysis (with a median follow-up of 38 months) of PALOMA-22#
  • The most common selected adverse events (≥10%, all causality)** of any grade reported in an updated non-prespecified analysis of PALOMA-2 for IBRANCE + letrozole vs placebo + letrozole were neutropenia (82% vs 6%), infections (63% vs 45%), leukopenia (40% vs 2%), fatigue (40% vs 28%), nausea (37% vs 27%), alopecia (34% vs 16%), stomatitis (32% vs 15%), diarrhea (28% vs 21%), anemia (26% vs 10%), rash (20% vs 13%), thrombocytopenia (20% vs 1%), asthenia (18% vs 12%), decreased appetite (17% vs 9%), vomiting (17% vs 17%), dry skin (13% vs 7%), pyrexia (13% vs 9%), alanine aminotransferase increased (13% vs 6%), aspartate aminotransferase increased (12% vs 6%), and dysgeusia (10% vs 5%)
Selected AEs reported in the final OS analysis (with a median follow-up of 90 months) of PALOMA-21,3††
  • The most common selected adverse events (≥10%, all causality)** of any grade reported in the final OS analysis of PALOMA-2 for IBRANCE + letrozole vs placebo + letrozole were neutropenia (82% vs 6%), infections (64% vs 46%), leukopenia (43% vs 3%), fatigue (41% vs 29%), nausea (38% vs 27%), alopecia (34% vs 16%), stomatitis (33% vs 15%), diarrhea (30% vs 23%), anemia (28% vs 10%), rash (22% vs 13%), thrombocytopenia (21% vs 2%), asthenia (19% vs 12%), decreased appetite (20% vs 10%), vomiting (18% vs 18%), dry skin (15% vs 7%), pyrexia (15% vs 9%), alanine aminotransferase increased (15% vs 6%), aspartate aminotransferase increased (14% vs 6%), and dysgeusia (NR vs NR)
In an updated non-prespecified PFS analysis and the final OS analysis, no new safety signals were observed.1-3NR=not reported.Based on May 2017 data cut (non-prespecified analysis), with a median follow-up of 38 months.2Incidences of AEs are all causality, and the AEs were selected based on their designation as Adverse Reactions (ARs, treatment-related) in PALOMA-2 in the IBRANCE Prescribing Information.²Based on November 2021 data cut (final OS analysis), with a median follow-up of 90 months.1,3References:Data on file. Pfizer Inc., New York, NY.Rugo HS, Finn RS, Diéras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat. 2019;174(3):719-729.Finn RS, Rugo HS, Diéras V, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer (ER+/HER2- ABC): analyses from PALOMA-2. Oral presentation at American Society of Clinical Oncology 2022 Annual Meeting; June 3-7, 2022; Chicago, IL.Discontinuations and dose reductionsPALOMA-2: IBRANCE + aromatase inhibitor

Discontinuations and dose reductions due to adverse reactions in PALOMA-2¹

 ALT=alanine aminotransferase; AR=adverse reaction; N/A=not applicable.Dose reductions of letrozole were not permitted in PALOMA-2. The dose reductions listed were of IBRANCE or placebo.Reference:Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.Neutropenia and lab abnormalities

PALOMA-2: IBRANCE + aromatase inhibitor

Neutropenia and lab abnormalities

Neutropenia
  • Neutropenia was the most frequently reported adverse event in PALOMA-2 (80%). Grade ≥3 neutropenia was reported in 66% of patients receiving IBRANCE + letrozole in PALOMA-2
  • Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia
  • Febrile neutropenia has been reported in 1.8% of patients exposed to IBRANCE. One death due to neutropenic sepsis was observed in PALOMA-3, the trial evaluating IBRANCE + fulvestrant
  • Advise patients to immediately report any signs or symptoms of myelosuppression or infection, such as fever, chills, dizziness, shortness of breath, weakness, or any increased tendency to bleed and/or to bruise
  • Primary prophylactic use of granulocyte-colony stimulating factors was not permitted in PALOMA‑2, but they could be used to treat treatment-emergent neutropenia as indicated by the current American Society of Clinical Oncology guidelines1
Neutropenia management in PALOMA-2
  • Dose reductions or dose modifications due to neutropenia occurred in 24.3% of patients taking IBRANCE + letrozole in PALOMA-21
  • 1.1% of patients discontinued IBRANCE due to neutropenia in PALOMA-2
Lab abnormalities
  • Lab abnormalities occurring in PALOMA-2 (all grades, IBRANCE + letrozole vs placebo + letrozole) were decreased white blood cells (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%)
Reference:Data on file. Pfizer Inc., New York, NY.
Warnings and precautions
IBRANCE + aromatase inhibitor in first-line mBCWarnings and precautionsNeutropenia
  • 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 (CBC) prior to starting IBRANCE, at the beginning of each cycle, on Day 15 of the 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
Interstitial lung disease (ILD)/pneumonitis
  • 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 grade0.1% had Grade 3 or 4No 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
Embryo-fetal toxicity
  • 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
AI=aromatase inhibitor; IBR=IBRANCE.Clinical Trial Data PALOMA-2 Perspectives

Dr. O’Dea reviews IBRANCE + AI (PALOMA-2) clinical trial data and discusses the impact it has on her decision to choose IBRANCE combination therapy for appropriate patients

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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%). 

Other Clinical Trials Experience: venous thromboembolism has been reported as an adverse reaction following administration of IBRANCE. 
 

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.

IndicationsIBRANCE® (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
Please see full Prescribing Information for IBRANCE capsules and tablets.