Pfizer To Submit NDA For Palbociclib Combined With Letrozole - Quick Facts

(RTTNews) - Pfizer Inc. (PFE) Friday said it will submit a New Drug Application with the U.S Food and Drug Administration, or FDA, for palbociclib, combined with letrozole, as first-line systemic treatment advanced or metastatic breast cancer in post-menopausal women.

This decision was based on discussions with the FDA regarding the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

Palbociclib has previously received Breakthrough Therapy designation from the FDA in April 2013. However, it is not approved for any indication in any market.

Pfizer expects to submit the NDA early in the third quarter of this year.