Pfizer Seeks Early Approval for Breast Cancer Drug
NEW YORK (AP) — Pfizer says the FDA will let the drugmaker apply for approval of its heavily touted experimental breast cancer medicine based on midstage patient testing results.
That means New York-based Pfizer won't need bigger, very expensive, late-stage patient studies for palbociclib (pal-boh-SEYE'-klihb) to be approved.
The company says that after discussions with the FDA, the final results of a study called PALOMA-1 will be sufficient for review. The FDA last year designated palbociclib a breakthrough therapy, which speeds up the testing and approval process.
Pfizer says that by the third quarter, it will apply for approval to use palbociclib, together with a drug to prevent breast cancer recurrence called Femara, or letrozole, as an initial treatment for postmenopausal women with a certain type of advanced breast cancer.