The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the supplemental New Drug Application (sNDA) for Ibrance (palbociclib), a Tx for breast cancer. If approved, Ibrance would be expanded for indication on women with hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+, HER2-) metastatic breast cancer, regardless of menopausal status, whose disease progressed after endocrine therapy.
The sNDA submission is based on findings from the Phase 3 trial, PALOMA-3, which evaluated Ibrance in combination with fulvestrant vs. fulvestrant plus placebo in 521 women with HR+, HER2- metastatic breast cancer whose disease progressed after endocrine therapy. The trial was halted early due to efficacy assessment performed by an independent Data Monitoring Committee (DMC). Results were presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) and were published in The New England Journal of Medicine in June 2015.
In February 2015, the FDA approved Ibrance for use in combination with letrozole as initial endocrine-based treatment for postmenopausal women with ER+, HER2- advanced breast cancer. In November 2015, Ibrance in combination with fulvestrant was added to the National Comprehensive Cancer Network Guidelines as a Category 1 recommendation for the treatment of women with HR+, HER2- metastatic breast cancer. Specifically patients who have progressed on endocrine therapy or premenopausal women receiving ovarian suppression with a luteinizing hormone-releasing hormone (LHRH) agonist.
Ibrance is an oral, first-in-class inhibitor of cyclin-dependent kinases (CDKs) 4 and 6.