- Palbociclib is intended for use in combination with letrazole, an aramatose inhibitor.
- Palbociclib was developed for the treatment of estrogen-positive, HER2-negative advanced breast cancer in women who have not previously received synthetic treatment.
- The New Drug Application (NDA) is based on phase II trial data showing that the palbociclib-based treatment significantly improved progression-free survival compared to using letrazole alone.
Data presented to the FDA earlier this year highlighted major differences between the median PFS in patients treated with the palbociclib-based treatment versus letrazole alone (20.2 months versus 10.2 months). The FDA must decide within 60 days if the NDA is acceptable for filing.
This drug has the potential to be a major blockbuster for Pfizer. According to Forbes, analysts believe palbocicilib has the potential to cross $10 billion in annual sales.