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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryP-REALITY X OverviewP-REALITY X OS and rwPFSP-REALITY X Subgroup analysis OverviewP-REALITY X:OS and rwPFS in Subgroup(Lung & Liver metastasisTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryMADELINE ASIA OverviewMADELINE ASIA Patient Reported OutcomesMADELINE ASIA SafetyMADELINE ASIA Study LimitationsDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

Monitoring

One Scheduled Monitoring ProvisionSupport & Resources

Summary of Prescibing Information

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For more than 7 years2, PALBACE® has been supported by broad clinical and real world experience, proven efficacy and favorable tolerability.1-32 

A) For Women1:

   

PALBACE® (palbociclib) is indicated for the treatment of HR+, HER2- locally ABC or mBC:

  • In combination with an AI
     
  • In combination with fulvestrant in women who have received prior ET

In premenopausal or perimenopausal women, ET should be combined with an LHRH agonist.

     

B) For Men1:

   

PALBACE® (palbociclib) is indicated for the treatment of HR+, HER2- ABC or mBC in combination with:

  • An AI as initial endocrine-based therapy
     
  • Fulvestrant in patients who have received prior therapy

Click here to see the Full Prescribing lnformation for tablet.

     

Click here to see the Full Prescribing lnformation for capsule.

  

  

 Clinical Efficacy & Safety

PALOMA was the first clinical trial
programme to explore how a CDK4/6
inhibitor could benefit women with
HR+/HER2- mBC

 Learn moreLoading Real-world Evidence

With RCT data, PALBACE® RWE can help
improve the understanding of outcomes in
patients with HR+/HER2- mBC

 Learn moreLoading Dosing

Recommended dosing schedule and dose
modifications for AEs

 Learn moreLoading Monitoring

One scheduled monitoring provision

 Learn moreLoading

  

Pfizer Products India Private Limited (Pfizer) The Capital – B Wing, 1802, Plot
No. C-70, G Block, Bandra Kurla Complex,
Bandra (East), Mumbai – 400 051, India.

® Trademark Proprietor – Pfizer Inc., USA
Licensed User – Pfizer Products India Private Limited, India 

To view the summary of prescribing information for PALBACE®, for tablet please click here, for capsule please click here.

For the use only of Registered Medical
Practitioners or a Hospital or a Laboratory.
Full prescribing information available on request.

  

ABC,  advanced breast cancer; AE, adverse event; AI, aromatase inhibitor; CDK, cyclin-dependent kinase; ET, endocrine treatment; HER2-, human epidermal growth factor 2-negative; HR+, hormone receptor-positive; LHRH, luteinising hormone-releasing hormone; mBC, metastatic breast cancer; RCT, randomised clinical trial; RWE, real-world evidence. 

  

References:

LPD Palbace(Palbociclib) prescribing document. Pfizer Products India Private Limited. Version 7, LPDPAB062023.

Data on File June 2023.

Cristofanilli M, et al. Clin Cancer Res.2022;28(16):3433-3442.

Xu B, et al. Eur J Cancer. 2022;175:236-245.

Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.

Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729.

Gelmon K, et al. Breast. 2021;59:321-326. Co-morbidities 

Rugo HS, et al. Eur J Cancer. 2018;101:123-133

Turner NC, et al. Ann Oncol. 2018;29(3):669-680.

Cristofanilli F, et al. Lancet Oncol. 2016;17(4):425-439. 

Goyal RK, et al. Cancer. 2023 Feb 9. Epub ahead of print. 

Richardson D, et al. Breast Cancer Res Treat. 

De Michele A, et al. Breast Cancer Res. 2021;23:37.

Rugo HS, et al. NPJ Breast Cancer. 2022; 8(1):114.

Taylor-Stokes G, et al. Breast. 2019;43:22-27.

Waller J, et al. J Glob Oncol. 2019;5:JGO1800239. 

Mycock K, et al. Future Oncol. 2022;18:349-362. 

Mycock K, et al. Curr Oncol. 2021;28:678-688. 

Mycock K, et al. Cancer Treat Res Commun. 2022;32:100573. Epub 6 May 2022. 

Mycock K, et al. Clin Ther. 2022;44(12):1588-1601.

Kraus AL, et al. Clin Pharmacol Ther. 2022;111(1):302-309.

Rugo HS, et al. SABCS 2022; Abstract P3-01-15.

De Laurentiis M, et al. SABCS. 2019; Poster P3-11-25.

Caillet P. ASCO 2021; Oral presentation 1012.

Tripathy D, et al. ESMO 2022; Poster 251P. 

Karuturi MS, et al. ESMO BC 2022; Poster 190P. 

Blum J, et al. SABCS 2021; Abstract P1-18-29. 

Finn R, et al. ASCO 2022; Oral presentation.

Finn R, et al. Oncologist. 2021;26:e749-e755.

Diéras V, et al. Oncologist. 2019;24:1514-1525.

Verma S, et al. Oncologist. 2016;21(10):1165-1175.

Kassaian SE, et al. Curr Cardiol Rep. 2022;24(11):1685-1698.

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.
All images used are for representation purposes only
(®)Trademark Proprietor: Pfizer Inc.USA Licensed User: Pfizer Products India Private Limited.India

    

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