Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Pfizer has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for palbociclib to treat postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.
Subscribe to our email newsletter
The NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment these women.
The filing is based on the final results of PALOMA-1, a randomized, Phase II trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.
The company received breakthrough therapy status from the FDA for Palbociclib in April 2013, to treat first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer.
The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing.
Pfizer Oncology president Garry Nicholson said, "Today’s submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer."
The PALOMA-1 Phase II trial was designed to evaluate progression-free survival in post-menopausal women with ER+, HER2- advanced breast cancer receiving palbociclib 125mg once daily for three out of four weeks in repeated cycles in combination with letrozole versus letrozole alone 2.5mg once daily on a continuous regimen.
Image: Pfizer world headquarters. Photo: courtesy of Jim.henderson.