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FDA expands approval of Faslodex for advanced breast cancer
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The FDA expanded the approval of fulvestrant to include monotherapy for postmenopausal women with hormone receptor-positive, HER-2-negative advanced breast cancer who have not received endocrine therapy, according to the agent’s manufacturer.
Fulvestrant (Faslodex, AstraZeneca) — a hormonal therapy that targets the estrogen receptor — already had been approved as monotherapy for postmenopausal women with hormone receptor-positive metastatic breast cancer whose disease progressed after anti-estrogen therapy, as well as in combination with palbociclib (Ibrance, Pfizer) for women with hormone receptor-positive, HER-2-negative advanced or metastatic breast cancer whose disease progressed after endocrine therapy.
“We’re pleased that the landmark FALCON trial results demonstrated the efficacy of Faslodex as initial monotherapy treatment for women who are living with hormone-receptor-positive, HER-2-negative advanced breast cancer,” Jamie Freedman, executive vice president and head of the oncology business unit at AstraZeneca, said in a company-issued press release. “This approval, building on more than 15 years of clinical experience, means more patients can have the opportunity to receive Faslodex earlier in the treatment journey.”
The FDA based the expanded approval on results from the randomized, phase 3 FALCON trial, designed to evaluate the efficacy and safety of fulvestrant compared with anastrozole (Arimidex, AstraZeneca), the current standard of care for first-line treatment of hormone receptor–positive advanced breast cancer.
Researchers randomly assigned 462 postmenopausal women with hormone receptor-positive metastatic or locally advanced breast cancer to 500 mg fulvestrant plus placebo or 1 mg anastrozole plus placebo.
Patients assigned fulvestrant demonstrated a 20% reduction in risk for disease progression or death. Researchers reported median PFS of 16.6 months in the fulvestrant group and 13.8 months in the anastrozole group (HR = 0.8; 95% CI, 0.64-1).
The most common adverse reactions in the fulvestrant group included arthralgia, hot flashes, fatigue and nausea.