FDA Approves Combination Treatment of Faslodex/Ibrance for Certain Metastatic Breast Cancers

FDA Approves Combination Treatment of Faslodex/Ibrance for Certain Metastatic Breast Cancers
The U.S. Food and Drug Administration (FDA) has approved expanding the use of AstraZeneca’s breast cancer drug Faslodex (fulvestrant), in combination with Pfizer’s Ibrance (palbociclib), to treat advanced breast cancers (BC). The combination can now be used to treat women with hormone receptor-positive (HR+)/human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer (MBC) whose disease has progressed after endocrine therapy. According to a press release, the FDA had initially approved Faslodex as a monotherapy for post-menopausal women with HR+ MBC, whose cancer had progressed after antiestrogen therapy. Data supporting this new decision was collected in the Phase 3 PALOMA-3 clinical trial, which demonstrated an average progression-free survival (PFS) increase of 4.9 months with Faslodex/Ibrance treatment, as opposed to Faslodex/placebo, in women with HR+/HER2-negative MBC whose disease had worsened after endocrine therapy. PFS improvement was not considered to be related to menopausal status. The study analyzed 521 pre- and post-menopausal women, 74 percent of whom were Caucasian. A total 25 percent of participants had not received any previous therapy in the MBC setting, 60 percent had visceral metastases, and 23 percent had bone-only metastases. Ibrance (palbociclib) was given via oral administration at 125 mg daily for 21 consecutive days, followed by seven days without treatment; Fulvestrant was given int
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