The European Medicines Agency has validated Pfizer’s application to market first-in-class Ibrance for breast cancer, clearing the final hurdle before an actual review.
The drug giant is seeking approval of Ibrance (palbociclib) in combination with endocrine therapy for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.
The submission rides on results from the PALOMA-1 and PALOMA-3 trials, which demonstrated “significant clinical benefit” for women with the disease taking Ibrance alongside endocrine therapy, according to Mace Rothenberg, chief medical officer at Pfizer Oncology.
PALOMA-1 showed first-line treatment with the Ibrance/letrozole combination boosted progression-free survival by around 50% compared to letrozole alone (20.2 months versus 10.2 months, respectively).
The data also formed the basis of a US approval for Ibrance - an oral inhibitor of cyclin-dependent kinases 4 and 6 - in February this year.