IBRANCE (palbociclib) is indicated for the treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with:
- an aromatase inhibitor as initial endocrine-based therapy in post-menopausal women or men; or
- fulvestrant in patients with disease progression after prior endocrine therapy. Pre- or perimenopausal women must also be treated with a luteinizing hormone releasing hormone (LHRH) agonist.
Clinical effectiveness of IBRANCE in combination with an aromatase inhibitor is based on the benefit observed in patients treated with IBRANCE in combination with letrozole for the treatment of postmenopausal women with advanced breast cancer.
Geriatrics (≥ 65 years of age):
Of 444 patients who received IBRANCE in PALOMA-2, 181 (41%) patients were ≥65 years of age. Of 347 patients who received IBRANCE plus fulvestrant, 86 patients (25%) were ≥65 years of age. No overall differences in the safety and efficacy of IBRANCE were observed between these patients and younger patients in either study. Anemia was reported more frequently in patients ≥65 than in patients <65 years of age treated with IBRANCE plus letrozole, whereas similar incidences were reported in both age groups for patients treated with IBRANCE plus fulvestrant.
Pediatrics (< 18 years of age):
Based on the limited data submitted and reviewed by Health Canada, the safety and efficacy of IBRANCE in pediatric patients have not been established; Therefore, Health Canada has not authorized an indication for pediatric use (See WARNINGS AND PRECAUTIONS, Special Populations; and ACTION AND CLINICAL PHARMACOLOGY, Special Populations).