Boston, MA 10/14/2014 (wallstreetpr) – Pfizer Inc. (NYSE:PFE) disclosed that the Food and Drug Administration has accepted its New Drug Application for its drug candidate, Palbociclib. The company indicated that the drug candidate is meant for the treatment of advanced breast cancer. The priority review indicates the speeding up of the process by four months’ time.
Not Approved For Any Indication
Pfizer Inc. (NYSE:PFE) said in a statement that Palbocicib has not been accorded approval for any indication in any market. Its NDA sought approval of its candidate in combination with letrozole with estrogen receptor positive or ER+ and human epidermal growth factor receptor-two negative or HER-2 advanced breast cancer. The target of combined drug was those who have not got systematic treatment previously for their advanced ailment.
Pfizer Inc. (NYSE:PFE) said that it submitted its NDA based on the final results of randomized, PALOMA-1, second stage study comparing Palbociclib along with letrozole and letrozole on a standalone. The priority review status would quicken the process to six months from ten months from the date of filing of NDA acceptance. It pointed out that such a review status was accorded when the drug candidate provided major treatment advancement or offer treatment in the absence of any sufficient therapy.
Pfizer Inc. (NYSE:PFE) disclosed that April 13 next year would be the goal date for the decision of the FDA as per the Prescription Drug User Fee Act. It was accorded Breakthrough Therapy designation in April last year by the FDA as a first-line systemic treatment of women affected by advanced or metastatic ER+ and HER-2 breast cancer.
Pfizer’s President for Oncology, Garry Nicholson, said that in case the FDA provides its nod for Palbociclib in combination with letrozole as a first-line treatment, it would benefits thousands of women in the Americas. He said that the company was looking to work closely with the regulator in the review process.
Recently, Pfizer Inc. (NYSE:PFE) disclosed the commencement of a multi-center and open-label expanded access program in the U.S. for Palbociclib.