Pfizer Announces that Palbociclib New Drug Application has been accepted by FDA

Pfizer Announces that Palbociclib New Drug Application has been accepted by FDA

Pharmaceutical major Pfizer has announced that the Drug Application (NDA) for Palbociclib has been accepted for filing and has also been granted Priority Review by the United States Food and Drug Administration (FDA).

Palbociclib is an investigational oral targeted agent that selectively inhibits the cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control by blocking tumor cell proliferation.1. Until now, Palbociclib is not approved for any indication in any market.

Palbociclib, in combination with letrozole, is a first-line treatment for postmenopausal women who have estrogen receptor positive (ER+). Along with this, it is a treatment for human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer for those who have not received any previous systemic treatment for their advanced disease.

The NDA requests FDA approval of Palbociclib. This submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing Palbociclib plus letrozole versus letrozole alone in the population of patients.

The FDA's Priority Review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing. Priority Review status is given to those classes of drugs that may offer major advances in treatment or may provide a treatment where no adequate alternate therapy exists till now.

The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015. Garry Nicholson, president, Pfizer Oncology said, "If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the U.S. who are living with metastatic breast cancer. We look forward to continuing to work closely with the FDA through the review process".

Pfizer has worked closely with investigators and international breast cancer experts so as to develop a robust program for Palbociclib in ER+, HER2- breast cancer across stages and treatment settings.

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