Pfizer Inc. PFE announced that the European Medicines Agency (EMA) has accepted for review its marketing application for Ibrance (palbociclib). Pfizer is looking to get Ibrance approved 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 validation marks the initiation of the EMA's review process.
We remind investors that Ibrance had received accelerated approval from the FDA in Feb 2015. The drug was approved in combination with Novartis AG’s NVS Femara (letrozole) for the first-line treatment of postmenopausal women with estrogen receptor-positive, HER2- advanced breast cancer as an initial endocrine-based therapy for their metastatic disease.
Pfizer is looking to submit a supplemental new drug application to the FDA in the fourth quarter of 2015 for the inclusion of data from the PALOMA-3 study in the U.S. label.
We note that PALOMA-3, a phase III study, evaluated Ibrance plus AstraZeneca’s AZN Faslodex (fulvestrant) versus Faslodex plus placebo in women with HR+/HER2- metastatic breast cancer whose disease has progressed after prior endocrine therapy.
Initial sales of Ibrance have been encouraging. The drug registered sales of $178 million in the first half of 2015 since its launch in Feb 2015.
We are encouraged by the acceptance of Ibrance for review in the EU. Approval in the EU would boost the drug’s sales further. We expect investor focus to remain on the commercialization and sales ramp up of Ibrance.
Meanwhile, Pfizer is working on expanding Ibrance’s label further by targeting different segments of breast cancer patients. The company is also exploring the possibility of developing Ibrance for additional tumor types including pancreatic, and head and neck cancer.
Pfizer currently carries a Zacks Rank #3 (Hold). Regeneron Pharmaceuticals, Inc. REGN is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
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