Pfizer receives expanded FDA approval for Ibrance in HR+, HER2- metastatic breast cancer

First-in-class therapy now approved for use in a broader range of women.

Ibrance first was approved in February 2015 and also is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine-based therapy in postmenopausal women. The indication in combination with letrozole is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory Phase III trial, PALOMA-2, is fully enrolled.

Ibrance is the first and only cyclin-dependent kinase 4/6 (CDK 4/6) inhibitor approved by the FDA.

“Today's news gives more women with metastatic breast cancer the opportunity to benefit from this first-in-class medicine," said Liz Barrett, global president and general manager, Pfizer Oncology. “Since Ibrance was approved just over one year ago, physicians across the US have embraced it as a standard of care in the first-line setting. The expanded approval of Ibrance is supported by a robust body of evidence and underscores Pfizer's continued commitment to addressing the needs of the metastatic breast cancer community. Pfizer is proud to bring forward innovative therapies like Ibrance that make a meaningful difference in patients' lives.”