Up to 70% of cases of breast cancer have mutations in the PI3K/Akt/mTOR pathway; hyperactivation of this pathway can contribute to endocrine resistance1-5
*Median PFS was 7.8 months with AFINITOR plus exemestane [95% CI, 6.9-8.5] vs 3.2 months [95% CI, 2.8-4.1] with placebo plus exemestane (HR=0.45 [95% CI, 0.38-0.54]; P<0.0001).1
AFINITOR® is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2-negative breast cancer (advanced HR+ BC) in combination with exemestane after failure of treatment with letrozole or anastrozole.
Important Safety Information
- AFINITOR is contraindicated in patients with hypersensitivity to everolimus, other rapamycin derivatives, or any excipients
- There have been reports of noninfectious pneumonitis, infections, and renal failure (including acute renal failure) in patients taking AFINITOR, some with fatal outcomes
- Oral ulceration is the most frequently occurring adverse event and occurred in 44% to 78% of AFINITOR-treated patients across the clinical trial experience. Most of these events were grade 1/2. Grade 3/4 stomatitis was reported in 4% to 9% of patients
- Exercise caution with the use of AFINITOR in the perisurgical period, as everolimus delays wound healing and increases the occurrence of wound-related complications
- In the randomized advanced hormone receptor-positive, HER2-negative breast cancer study, the incidences of deaths due to any cause within 28 days of the last AFINITOR dose and adverse reactions leading to permanent treatment discontinuation were greater in patients ≥65 years of age compared with patients <65 years of age
- Elevations of serum creatinine, proteinuria, glucose, lipids, and triglycerides, and reductions of hemoglobin, lymphocytes, neutrophils, and platelets have also been reported; monitoring of laboratory tests is recommended
- The use of live vaccines and close contact with those who have received live vaccines should be avoided
- AFINITOR can cause fetal harm when administered to a pregnant woman
Please see additional Important Safety Information.
Please see full Prescribing Information for AFINITOR.