Boston, MA 08/19/2014 (wallstreetpr) – Research-based global pharmaceutical firm Pfizer Inc. (NYSE:PFE) had submitted a New Drug Application or NDA to the Food and Drug Administration or the FDA for its palbociclib. The company seeks the FDA permission of palbociclib to be combined with letrozone for treating postmenopausal women of estrogen receptor positive or ER+, or negative human epidermal growth factor receptor 2 or HER2- advanced cancer.
NDA Submission for Palbociclib
The company disclosed that the NDA submission was based on the ultimate results of randomized, stage 2 trial of PALOMA-1 that compared palbociclib with letrozole and letrozole alone. In April 2013, FDA had accorded Breakthrough Therapy designation for Pfizer Inc. (NYSE:PFE)’s Palbociclib for the first-line general treatment of women affected by advanced or metastatic ER+ or HER2- breast cancer. The regulator had assigned the designation based on the PALOMA-1 trial’s interim data.
The company stated that the medical regulator would review its NDA application during the 60-day filing review time in all respects before accepting it for filing. However, the pharmaceutical company believes that the submission was an important milestone and a possible advance for the treatment of advanced breast cancer.
Palbociclib
Pfizer Inc. (NYSE:PFE) said that a palbociclib is an investigational oral agent, which selectively slowdown cyclin-dependent kinases or CDKs 4 and 6 to recover cell cycle control apart from block tumor cell proliferation. For the cancer, loss of cell cycle control was a hallmark. And CDK 4/6 were over-activated in number of cancers thus driving a loss of proliferative control.
The company indicated that CDK 4/6 were important for many reasons including triggering cellular progression from the growth phase and its percolation connected with DNA replication. The company also said that palbociclib is not available in any market for any indication with FDA permission.
Pfizer Inc. (NYSE:PFE) said that it had been working with global breast cancer experts and investigators to develop a strong development program for its palbociclib in HER2- or ER+ in different stages and treatment settings.
