TRENTON, N.J. (AP) — Pfizer Inc. said Friday that the Food and Drug Administration 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 have to do bigger, and very expensive, late-stage patient studies to apply for approval of palbociclib, as company executives and investors had hoped.
Having to run those additional studies could have delayed Pfizer's application by up to a couple of years, keeping patients and doctors waiting and ultimately reducing how much money the drug could bring Pfizer before its 20-year patent expires.
Pfizer, the world's second-biggest drugmaker by revenue, said that after discussions with the FDA, the final results of a study called PALOMA-1 will be sufficient for review.
Pfizer said that by the third quarter of this year, it will apply for approval to use palbociclib with a drug called Femara, or letrozole, as an initial treatment for postmenopausal women with a certain type of advanced breast cancer.
The FDA last year named palbociclib a breakthrough therapy, a designation given to medicines for diseases with no or inadequate treatments. It's meant to speed up the testing and approval process. The designation was based on interim results from the PALOMA-1 study.