FDA approves breast cancer therapy for additional indications
The FDA recently approved Ibrance, an oral therapy developed by pharmaceutical company Pfizer Inc., for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
For this indication, Ibrance was approved for use in combination with fulvestrant in women who have experienced disease progression despite adherence to endocrine therapy.
Ibrance received FDA approval in February 2015 as a therapy for metastatic breast cancer. The only FDA-approved therapy of its kind, Ibrance is a cyclin-dependent kinase inhibitor.
“(Ibrance’s approval) gives more women with metastatic breast cancer the opportunity to benefit from this first-in-class medicine,” Liz Barrett, global president of Pfizer Oncology, said. “Since Ibrance was approved just over one year ago, physicians across the U.S. 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.”
For the new indication, the FDA granted Ibrance breakthrough therapy designation, as well as priority review, after Pfizer researchers completed a phase-three trial on the drug that used as subjects 521 women.