Pfizer: Palbocicib Slows Progression Of Recurrent Breast Cancer

(RTTNews) - Pfizer Inc. (PFE) said that study results showed that palbociclib in combination with fulvestrant was superior to treatment with a standard of care, fulvestrant.

Data showed that that palbociclib in combination with fulvestrant significantly extended progression-free survival in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer whose disease has progressed during or after endocrine therapy.

Results from the Phase 3 PALOMA-3 study will be featured today in a press briefing during the 51st Annual Meeting of the American Society of Clinical Oncology or ASCO and will be presented as a late-breaker on Monday, June 1 at 8:00 a.m. CDT. The results will also be simultaneously published online by The New England Journal of Medicine.

PALOMA-3, also known as Study A5481023, is a multi-center trial with more than 140 global sites participating and 521 patients enrolled. The study is a randomized, double-blind Phase 3 study.

Based on the results of PALOMA-3, Pfizer is in talks with global regulatory authorities to determine next steps to potentially make palbociclib available for women with HR+, HER2- metastatic breast cancer whose disease has progressed following endocrine therapy.

Pfizer has previously said it plans to file a Marketing Authorisation Application for palbociclib to the European Medicines Agency or EMA in the second half of 2015. In addition, Pfizer will work closely with the FDA to review these data and determine next steps for potential inclusion in the U.S. label.