
Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial.
The FDA has a 60-day filing review period to determine whether the NDA is complete and acceptable for filing. Pfizer will communicate the Agency’s decision.
“Today’s submission marks an important milestone for Pfizer and palbociclib, and a potential advance for women with advanced breast cancer,” said Garry Nicholson, president, Pfizer Oncology.
Date: August 18, 2014
Source: Pfizer