A) For Women:
PALBACE® (palbociclib) is indicated for the treatment of HR+, HER2- locally ABC or mBC:
In premenopausal or perimenopausal women, ET should be combined with an LHRH agonist.
B) For Men:
PALBACE® (palbociclib) is indicated for the treatment of HR+, HER2- ABC or mBC in combination with:
Click here to see the Full Prescribing lnformation for tablet.
Click here to see the Full Prescribing lnformation for capsule.
A broad range of women with HR+/HER2- mBC may beneﬁt from PALBACE® combination therapy.1-9 PALBACE® is the first CDK4/6 inhibitor supported by data from clinical trials1-4 and RWE.5-7
PALOMA was the first clinical trial
programme to explore how a CDK4/6
inhibitor could benefit women with
With RCT data, PALBACE® RWE can help
improve the understanding of outcomes in
patients with HR+/HER2- mBC
Recommended dosing schedule and dose
modifications for AEs
One scheduled monitoring provision
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No. C-70, G Block, Bandra Kurla Complex,
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® 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; QoL, quality of life; RCT, randomised clinical trial; RWE, real-world evidence.
Palbace. Local product document. Pfizer; 2021. Version LPDPAB102021.
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.
Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial [published correction appears in Lancet Oncol. 2016;17(4):e136] [published correction appears in Lancet Oncol. 2016;17(7):e270]. Lancet Oncol. 2016;17(4):425-439.
Cristofanilli M, Rugo HS, Im SA, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): updated analyses from PALOMA-3. Presented at: ASCO 2021 Annual Meeting; June 5, 2021; Virtual.
Rugo HS, Cristofanilli M, Loibl S, et al. Prognostic factors for overall survival in patients with hormone receptor-positive advanced breast cancer: analyses from PALOMA-3. Oncologist. 2021;26(8):e1339-e1346.
DeMichele 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.
Taylor-Stokes G, Mitra D, Waller J, Gibson K, Milligan G, Iyer S. Treatment patterns and clinical outcomes among patients receiving palbociclib in combination with an aromatase inhibitor or fulvestrant for HR+/HER2-negative advanced/metastatic breast cancer in real-world settings in the US: results from the IRIS study. Breast. 2019;43:22-27.
Waller J, Mitra D, Mycock K, et al. Real-world treatment patterns and clinical outcomes in patients receiving palbociclib for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in Argentina: the IRIS study. J Glob Oncol. 2019;5:JGO1800239.
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For more details on, Who is a Registered medical practitioner*, please visit https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/acts_rules/2016DrugsandCosmeticsAct1940Rules1945.pdf , Page No. 39, Rule 2 part (ee), last accessed on 26th April 2021.
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