Boston, MA 08/20/2014 (wallstreetpr) – According to reports, Pfizer Inc. (NYSE:PFE) has decided to submit the marketing application for Palbociclib; oncology candidate of the company to the FDA. The company wants to get approval in regard with approval of Femara (letrozole) of Novartis. It is used for the treatment of postmenopausal women with estrogen receptor-positive and human epidermal growth factor receptor two-negative. Only those candidates who have not received any previous treatment will be considered this time.
What prompted PFE to file a new application?
Pfizer Inc. (NYSE:PFE) conducted phase II PALOMA-1 study in which it got superb results. On the basis of encouraging results that it received, PFE decided to file a new application. Reports claim that combination treatment of Femara and palbociclib resulted into the progression-free survival (PFS) versus Femara in all those women who were diagnosed with metastatic breast cancer. Earlier when PALOMA-1 study was conducted a couple of years back, FDA decided to grant Breakthrough Therapy designation to palbociclib for the treatment of breast cancer in Apr 2013.
At present Pfizer Inc. (NYSE:PFE) is conducting two phase III studies on PALOMA-3 and PALOMA-2 for the first-line systemic treatment of those women who have metastatic or advanced ER+, HER2- breast cancer. The current PALOMA-2 study is trying to evaluate the combination of Femara and palbociclib in the similar patent population like PALOMA-1. The company has tried several steps in past to approve the application, but sometimes the results were not up to the mark while sometimes it was not 100% ready.
The current PALOMA-3 study has been conducted by the Pfizer Inc. (NYSE:PFE) with all the preliminary requisites. Its main focus is to evaluate the Faslodex of AstraZeneca (AZN) plus palbociclib versus placebo in women with extensive hormone receptor-positive plus Faslodex. It has got Zacks Rank #3 (Hold) after the positive results it has got in near past. The management of the company expects to perform better in the future.
