March 03, 2016
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FDA approves use of Faslodex in combination with Ibrance

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The FDA expanded the approval of fulvestrant to include its use in combination with palbociclib for women with advanced breast cancer.

The combination is indicated for treatment for women with hormone receptor-positive, HER-2–negative metastatic breast cancer whose disease progressed after endocrine therapy.

The FDA initially approved fulvestrant (Faslodex, AstraZeneca) in 2002 for monotherapy of postmenopausal women with hormone receptor-positive metastatic breast cancer whose disease progressed after antiestrogen therapy.

The agency based the expanded approval on results of the phase 3 PALOMA-3 trial, which evaluated use of fulvestrant with or without palbociclib (Ibrance, Pfizer) in women with hormone receptor-positive, HER-2–negative advanced or metastatic breast cancer who progressed after endocrine therapy.

PFS served as the primary endpoint.

Results showed women assigned fulvestrant plus palbociclib achieved a 4.9-month improvement in median PFS compared with those assigned fulvestrant plus placebo. Researchers observed the PFS improvement regardless of menopausal status.

The most common adverse reactions reported among women assigned the combination included neutropenia (83% for combination vs. 4% for fulvestrant alone), leukopenia (53% vs. 5%), infections (47% vs. 31%), fatigue (41% vs. 29%), nausea (34% vs. 28%), anemia (30% vs. 13%), stomatitis (28% vs. 13%), headache (26% vs. 20%), diarrhea (24% vs. 19%) and thrombocytopenia (23% vs. 0%).

“We believe that advances in cancer treatment will come, in part, from our research building upon existing treatments,” Andrew Coop, vice president for U.S. medical affairs/oncology at AstraZeneca, said in a press release. “This new indication adds to the existing body of evidence supporting Faslodex-based therapy for certain metastatic breast cancer patients in an area where there is still a high unmet medical need.”