The Food and Drug Administration has approved fulvestrant (Faslodex) as monotherapy for women with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2–) advanced breast cancer who are postmenopausal and previously untreated.

Approval was based on improved progression-free survival (PFS) in the phase 3 FALCON trial of 462 postmenopausal women with HR+/HER2– metastatic or locally advanced breast cancer who had not previously received hormonal therapy, drug maker AstraZeneca said in a press release .

Median PFS was 16.6 months in the fulvestrant group versus 13.8 months in the anastrozole group (hazard ratio, 0.797; 95% confidence interval, 0.637-0.999; P = .049).

The most common adverse events were arthralgia (16.7% of patients on fulvestrant vs. 10.3% on anastrozole), and hot flushes/flashes (11.4% vs. 10.3%).

Grade 3 or greater adverse events occurred in 22.4% vs. 17.7%. Deaths from adverse events occurred in six patients on fulvestrant vs. seven on anastrozole, according to results published in The Lancet.


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