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.
For comments and feedback contact: editorial@rttnews.com
Business News
May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.