Everolimus in combination with exemestane is now endorsed on both sides of the Atlantic for the treatment of advanced hormone receptor–positive breast cancer that is also HER2-negative.
Approval by the European Commission, announced by drugmaker Novartis on July 30, closely follows approval by the Food and Drug Administration July 20 and a favorable recommendation by the European Medicines Agency June 21. The EC and the FDA specify that the combination is to be used in patients whose breast cancer has recurred or progressed after treatment with an aromatase inhibitor.
The regulators based their decisions on results of the randomized, placebo-controlled, phase III BOLERO-2 trial. In that study, adding everolimus (Afinitor) to exemestane (Aromasin) increased median progression-free survival from 3.2 to 7.8 months in women whose disease had advanced after treatment with letrozole (Femara) or anastrozole (Arimidex).
Everolimus is the first mTOR inhibitor approved in breast cancer. It also has indications in pancreatic cancer, kidney cancer, and subependymal giant cell astrocytoma.
Results of the BOLERO-II trial were presented in December at the annual San Antonio Breast Cancer Symposium. Dr. Howard Burris, Dr. Hope Rugo, and Dr. William Gradishar, editors of The Oncology Report, discuss these findings in the video below: