Posted by Michael Wonder on 21 Dec 2016
FDA accepts supplemental new drug application for Pfizer’s Ibrance (palbociclib) in HR+, HER2- metastatic breast cancer
21 December 2016 - sNDA includes data from Phase 3 PALOMA-2 trial to support conversion from accelerated approval to regular approval.
Pfizer today announced that the U.S. FDA has accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, Ibrance (palbociclib). The sNDA supports the conversion of the accelerated approval of Ibrance in combination with letrozole to regular approval and includes data from the Phase 3 PALOMA-2 trial, which evaluated Ibrance as initial therapy in combination with letrozole for post-menopausal women with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer. This is the same patient population as the randomised Phase 2 PALOMA-1 trial upon which the accelerated approval of Ibrance plus letrozole was granted in February 2015.
The sNDA was granted priority review status, which accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing. The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2017.
