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MOA MOA MOA EfficacyEfficacyPALOMA-2 Study designPatient Characteristics Primary endpoint Secondary end point PALOMA-3Study design Patient Characteristics Primary endpoint Secondary end point SurvivalFinal analysis Subgroup analysis Prespecified groups Updated Subgroup analysis Safety Safety PALOMA pooled analysis Adverse reactions  & Laboratory abnormalities PALOMA 2 Adverse Events PALOMA 3 Adverse Events IBRANCE consistent  safety profile Pooled analysis of patients aged ≥65 years in the PALOMA trials No evidence of cumulative or delayed toxicity with up to 50 months Patients with visceral diseases GI ,  Liver toxicities, and QTC Dosing Dosing Once daily dosing Dose Modification Real-World EvidenceReal-world EvidenceIBRANCE is the only CDK4/6 inhibitor with >5 years of real-world experience Real-world data provide additional information Favorable progression free rates IRIS Study In the real world, IBRANCE benefits GuidelinesGuidelinesNCCN Guidelines ESMO Guidelines

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Information on how to access Ibrance® (palbociclib) prescribing information and adverse event reporting can be found at the bottom of the page.
IBRANCE has a well-characterised and consistent safety profile1-4AR = adverse reaction; ALT = alaninine aminotransaminase; AST = aspartate aminotransferase.; PALOMA-1 = Palbociclib: ongoing trials in the management of breast cancer; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PFS = progression-free survival; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3.

References: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 2. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439. 3. Verma S, et al. Oncologist. 2016;21(10):1165-1175. 4. Diéras V, et al. J Natl Cancer Inst. 2019;111(4):419-430. 5. Ibrance® (palbociclib) Local Product Document. Revision Date: September 2023 for UAE, Bahrain, Kuwait, Oman & Qatar. 6. Diéras V, et al. Oncologist. 2019;24(12):1514-1525.IBRANCE has a well-characterised and consistent safety profile1-4AE = adverse event; ALT = alanine aminotransferase; AST = aspartate aminotransferase; ET = endocrine therapy; PALOMA-1 = Palbociclib: ongoing trials in the management of breast cancer; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PFS = progression-free survival; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3;  QTc = QT interval corrected for heart rate; TEAE = treatment-emergent adverse event.

References: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 2. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439. 3. Verma S, et al. Oncologist. 2016;21(10):1165-1175. 4. Diéras V, et al. J Natl Cancer Inst. 2019;111(4):419-430. 5. Rugo HS, et al. Eur J Cancer. 2018;101:123-133. 6. Turner NC, et al. Ann Oncol. 2018;29(3):669-680. 7. Ibrance® (palbociclib) Local Product Document. Revision Date: September 2023 for UAE, Bahrain, Kuwait, Oman & Qatar. 8. Durairaj C, et al. Anticancer Drugs. 2018;29(3):271-280.In an exploratory, pooled analysis of patients aged ≥65 years in the PALOMA trials, the TEAEs reported were generally consistent with the known AE profile of IBRANCE1PALOMA Pooled Analysis: TEAEs Occurring in ≥10% of Patients ≥65 Years Old in Either Treatment group1
  • Few patients aged 65 to >75 years (up to 6%) discontinued because of TEAEs.1
Adapted from Rugo HS, et al. 2018.1
Data cut-off dates: 2 January 2015 for PALOMA-1, 26 February 2016 for PALOMA-2 and 23 October 2015 for PALOMA-3. *Patients in PALOMA-1 and PALOMA-2 received IBRANCE + LET; patients in PALOMA-3 had endocrine-resistant mBC and received IBRANCE + FUL.
†Includes LET alone in PALOMA-1, LET + PLA in PALOMA-2 and FUL + PLA in PALOMA-3.
‡All-causality AEs occurring in ≥10% of patients aged ≥65 years in the as-treated populations were graded in accordance with the maximum grade per CTCAE, version 3.0 (PALOMA-1) or 4.0 (PALOMA-2 and PALOMA-3) and classified according to MedDRA, version 19.0.
§Clustered PTs defined as follows: Anaemia includes the PTs anaemia, haematocrit decreased and haemoglobin decreased; infections includes any reported PTs of the System Organ Class Infections and infestations; leukopenia includes the PTs Leukopenia and White blood cell count decreased; neutropenia includes the PTs Neutropenia and Neutrophil count decreased; thrombocytopenia includes the PTs Platelet count decreased and Thrombocytopenia; stomatitis includes the PTs Aphthous stomatitis, Cheilitis, Glossitis, Glossodynia, Mouth ulceration, Mucosal inflammation, Oral pain, Oropharyngeal discomfort, Oropharyngeal pain and Stomatitis.
AE = adverse event; CTCAE = Common Terminology Criteria for Adverse Events; ET = endocrine therapy; FUL = fulvestrant; LET = letrozole; mBC = metastatic breast cancer; MedDRA = Medical Dictionary for Regulatory Activities; PALOMA-1 = Palbociclib: ongoing trials in the management of breast cancer; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3; PLA = placebo; TEAE = treatment-emergent adverse event.

Reference: 1. Rugo HS, et al. Eur J Cancer. 2018;101:123-133.

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