Pfizer is moving forward with Ibrance breast cancer drug as the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA), the company said on Wednesday.
The sNDA supports the conversion of the accelerated approval of Ibrance in combination with letrozole to regular approval, for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.
This is the same patient population as the randomized Phase 2 PALOMA-1 trial upon which the accelerated approval of Ibrance plus letrozole was granted in February 2015.
“Since its introduction in 2015, more than 45,000 patients have been prescribed Ibrance by more than 9,000 providers in the U.S.,” said Liz Barrett, global president and general manager, Pfizer Oncology. “We are pleased that the PALOMA-2 trial has further demonstrated the significant clinical benefit of Ibrance in the first-line setting, providing additional evidence for its continued use as a standard of care medicine.”
Ibrance is the first and only FDA approved oral inhibitor of CDKs 4 and 6,2 which are key regulators of the cell cycle that trigger cellular progression. It is approved in more than 50 countries.
Pfizer stock price on Dec 21, at 4:02 PM was 32.40, NYSE.