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Summary of Prescibing Information
PALOMA was the first clinical trial programme to investigate how a CDK4/6 inhibitor could benefit women with HR+/HER2- ABC¹ and is now also the first to be supported by RWE.2
PALOMA clinical trial programme
PALBACE® has been evaluated in 3 RCTs with ~1300 women with HR+/HER2- advanced or mBC as part of Pfizer’s robust PALOMA clinical trial programme.6,10,11
ABC, advanced breast cancer; CDK, cyclin-dependent kinase; EMA, European Medicines Agency; ER+/ HER2-, oestrogen receptor-positive/human epidermal growth factor receptor 2-negative; ET, endocrine therapy; FDA, Food and Drug Administration; HR+/ HER2-, hormone receptor-positive/human epidermal growth factor receptor2-negative; mBC, metastatic breast cancer; PALOMA, PALbociclib: Ongoing trials in the Management of breast cAncer; QT, time from the beginning of the QRS complex to the end of the T wave as shown on the electrocardiogram; RWE, real-world evidence.
References:
McCain J. First-in-class CDK4/6 inhibitor palbociclib could usher in a new wave of combination therapies for HR+, HER2- breast cancer. P T. 2015;40(8):511-520.
Ibrance. Data on file.
Study of letrozole with or without palbociclib (PD-0332991) for the first-line treatment of hormone-receptor positive advanced breast cancer. ClinicalTrials.gov identifier: NCT00721409. Updated November 4, 2019. Accessed September 13, 2023. https://clinicaltrials.gov/ct2/show/NCT00721409
A Study of palbociclib (PD-0332991) + letrozole vs. Letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer (PALOMA-2). ClinicalTrials.gov identifier: NCT01740427. Updated April 12, 2022. Accessed September 13, 2023. https://clinicaltrials.gov/ct2/show/NCT01740427
Palbociclib (PD-0332991) Combined with fulvestrant in hormone receptor+ HER2-negative metastatic breast cancer after endocrine failure (PALOMA-3). ClinicalTrials.gov identifier: NCT01942135. Updated February 16, 2022. Accessed September 13, 2023. https://clinicaltrials.gov/ct2/show/NCT01942135
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.
Palbociclib (Ibrance) resources for information. Approved drugs. US Food and Drug Administration. Accessed September 13, 2023. https://www.fda.gov/drugs/resources-information-approved-drugs/palbociclib-ibrance
Ibrance. European Medicines Agency. Updated March 3, 2020. Accessed September 13, 2023. https://www.ema.europa.eu/en/medicines/human/EPAR/ibrance
Ibrance. Capsules FDA supplement approval. FDA. Updated April 4, 2019. Accessed September 13, 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207103Orig1s008ltr.pdf
Finn RS, Crown JP, Lang I, et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015;16(1):25-35.
Finn RS, Martin M, Rugo HS, et al. Palbociclib and letrozole in advanced breast cancer. N Engl J Med. 2016;375(20):1925-1936.
Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
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PP-IBR-IND-0626 September 2023
PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC
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