Credit: Shutterstock photoPfizer Inc.PFE announced positive top-line results from a phase III (PALOMA-2) study on its breast cancer drug, Ibrance. The study achieved its primary endpoint of progression-free survival (PFS).
Results from the study revealed that a combination treatment of Ibrance and Novartis AG's NVS Femara led to an improvement in PFS when compared to Femara plus placebo in post-menopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) advanced or metastatic breast cancer who haven't received previous systemic treatment for their advanced disease.
Pfizer intends to present detailed efficacy and safety data from the study at the annual meeting of the American Society of Clinical Oncology. The company said that the phase III study results will support additional regulatory submissions for Ibrance across the globe and will also help the company in converting accelerated approval to full approval in the U.S.
We remind investors that Ibrance received accelerated approval from the FDA in Feb 2015. The drug was approved in combination with Femara for the treatment of postmenopausal women with ER+, HER2- advanced breast cancer as an initial endocrine-based therapy for their metastatic disease.
Earlier this year, the FDA approved a label expansion for Ibrance for the treatment of hormone receptor-positive (HR+), HER2-advanced or metastatic breast cancer in combination with AstraZeneca plc's AZN Faslodex whose disease has progressed following endocrine therapy.
We note that Ibrance in combination with endocrine therapy for the treatment of HR+, HER2- advanced or metastatic breast cancer is under review in the EU. The company plans to submit PALOMA-2 study data to support the ongoing review.
Ibrance has been off to a strong start and registered sales of $723 million in 2015. The drug's label and geographical expansion would boost its commercial potential significantly. We expect investor focus to remain on the commercialization and sales ramp up of Ibrance.
Pfizer is a Zacks Rank #3 (Hold) stock. Emergent BioSolutions, Inc. EBS is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
