
That means New York-based Pfizer won’t have to do bigger, and very expensive, late-stage patient studies of palbociclib (pal-boh-SEYE’-klihb).
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.
Date: May 16, 2014
Source: Associated Press
Filed Under: Drug Discovery