Faslodex(fulvestrant)

Faslodex (fulvestrant) is indicated for the treatment of postmenopausal women with estrogen receptor-positive advanced breast cancer that has progressed or relapsed after previous endocrine therapy. The regulatory submission for Faslodex (NDA/BLA 021344) included a proposed dosage change from 250 mg to 500 mg, with the efficacy supplement submitted on November 12, 2009, and a PDUFA date of September 13, 2010.

In a randomized, double-blind, parallel-group, multicenter, Phase III study (CONFIRM), the median overall survival was 22.8 months. For patients with prior aromatase inhibitor use, the median time to progression (TTP) was 5.4 months for Fulvestrant 500 mg versus 4.1 months for Fulvestrant 250 mg, with a TTP hazard ratio of 0.85 (p-value 0.195). The objective response rate for Faslodex 250 mg in patients under 65 years was 22%. Complete response with fulvestrant 500 mg was observed in 1.7% of patients.

Common safety findings for Faslodex 500 mg included injection site pain (11.6% of patients), nausea (9.7% of patients), and bone pain (9.4% of patients). For Faslodex 250 mg, nausea was reported in 13.6% of patients, back pain in 10.7% of patients, and injection site pain in 9.1% of patients. Increased hepatic enzymes (AST, ALT, ALP) of ≥1 CTC grade occurred in >15% of patients, with Grade 3-4 increases in 1-2% of patients. Injection site reactions were observed in 7% of patients with a single 5 mL injection of Faslodex 250 mg, and 27% with 2 x 2.5 mL injections.