The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Ibrance (palbociclib; Pfizer) based on data from the Phase 3 PALOMA-2 trial. This decision converts the FDA’s accelerated approval to regular approval and expands the anti-hormonal therapy that may be given with Ibrance.
Ibrance is now indicated for use with an aromatase inhibitor, broadening its initial indication for use in combination with letrozole, as initial endocrine-based therapy in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
The updated approval was based on data from the PALOMA-2 trial, which demonstrated that Ibrance + letrozole significantly extended progression-free survival (PFS) vs. letrozole + placebo. The median PFS of Ibrance + letrozole was >2 years, exceeding the median PFS for placebo + letrozole by >10 months (24.8 months, 95% CI: 22.1, NE vs. 14.5 months, 95% CI: 12.9, 17.1; HR 0.58, 95% CI: 0.46, 0.72; P<0.0001). This correlated to a 42% reduction in the risk of disease progression.
Ibrance, a CD4K 4/6 inhibitor, is also indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.
Ibrance is available as 75mg,100mg, and 125mg strength capsules in 21-count bottles.
For more information call (800) 438-1985 or visit Ibrance.com.