Ibrance approval cemented as competition comes into view
In February 2015, Pfizer's Ibrance (palbociclib) was granted accelerated approval by the FDA for treatment of newly diagnosed HR+ (hormone receptor positive) / HER2- breast cancer in post-menopausal women. A condition of this early licence was that the drug would continue to a post-marketing PIII trial.
Yesterday (June 6th) the results of this (PALOMA-2) trial were presented at ASCO, demonstrating and confirming the 10-month improvement on progression free survival (PFS). This is good news as although a negative result at PIII was not anticipated, since gaining approval in 2015 Ibrance is already the most utilized regimen as first-line therapy for postmenopausal HR+ metastatic breast cancer patients in the US.
This confirmation could assist Ibrance in terms of achieving filings for first-line use elsewhere, however it may soon face competition in the form of Eli Lilly's abemaciclib and potentially combination therapies involving Afinitor (everolimus, Novartis).