FDA Expands Indication for Fulvestrant Combination to HR+/HER2- Breast Cancer

Fulvestrant (Faslodex) plus abemaciclib may improve progression-free survival among patients with advanced or metastatic breast cancer.

The FDA recently announced the approval of fulvestrant (Faslodex) plus abemaciclib for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer, according to a press release.

The expanded indication now extends the treatment to patients whose disease progressed after endocrine therapy.

“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,” said Dave Fredrickson, executive vice president, head of the Oncology Business Unit at AstraZeneca. “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.”

The new approval was based on findings from the phase 3 MONARCH 2 clinical trial, which met the primary endpoint of progression-free survival (PFS). Included in the study were 699 women with HR+/HER2- advanced breast cancer who were randomized to receive intramuscular fulvestrant 500-mg plus abemaciclib 150-mg or placebo twice daily.

The investigators found that the fulvestrant plus abemaciclib combination increased PFS by 7.1 months compared with fulvestrant plus placebo, according to the release.

Previously, the FDA approved fulvestrant plus palbociclib for the treatment of patients with HR+/HER2- metastatic breast cancer whose disease progressed after endocrine therapy, according to the release. Fulvestrant is also approved in more than 80 countries as a monotherapy for estrogen receptor positive advanced breast cancer.

AstraZeneca reports that fulvestrant is currently being investigated as a combination therapy for patients with HR+ advanced breast cancer.

“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,” Peter A. Kaufman, MD, of the Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center. “The study supporting this indication demonstrated that Faslodex used in combination with abemaciclib significantly improves progression-free survival compared to Faslodex and placebo.”