The U.S. Food and Drug Administration (FDA) expanded to use of AstraZeneca’s Faslodex (fulvestrant) to include it in combination with Verzenio (abemaciclib) to treat HR-positive, HER2-negative advanced or metastatic breast cancer in women whose disease progressed after hormonal therapy.
The approval is the result of data demonstrating that combined therapy improved progression-free patient survival by 7.1 months, compared to those receiving Faslodex alone.
“Faslodex has long been an effective monotherapy option for women with hormone receptor-positive breast cancer, which is the most common type of advanced breast cancer,” Dave Fredrickson, executive vice president, head of the Oncology Business Unit at AstraZeneca, said in a press release.
“Today’s decision builds upon the recent approval for Faslodex in the first-line advanced setting and is supported by strong evidence to use this medicine within a combination therapy for advanced breast cancer. Combining Faslodex with abemaciclib provides patients with another effective, non-chemotherapy option to combat this disease.”
Verzenio, developed by Eli Lilly, is a drug blocking the CDK4/6 enzyme. The combination was studied in the Phase 3 MONARCH 2 study (NCT02107703) that included 669 women with breast cancer that produced the hormone receptor (HR) but not the human epidermal growth factor receptor 2 (HER2).
These women’s cancer had progressed on or after endocrine therapy. For most patients in the trial, the endocrine therapy had been their first breast cancer treatment. Participants were randomly assigned the Faslodex and abemaciclib combo or Faslodex with a placebo.
Results, released in July 2017, showed that women treated with the combination survived without disease progression for 16.4 months. Those receiving Faslodex with placebo had a progression-free survival of 9.3 months. This was translated to a nearly halved risk of progression in the combination group.
“This new indication for Faslodex offers another treatment option for women living with HR+, HER2- advanced or metastatic breast cancer with disease progression after endocrine therapy,” said Peter Kaufman, a doctor at the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center.
The FDA has earlier approved Faslodex for use with another CDK4/6 inhibitor — Pfizer’s Ibrance (palbociclib) — in the same patient group.