Arimidex -----用于绝经后乳腺癌

Generic Drug Name

anastrozole

Trade Name

Arimidex

Sponsor or Applicant

AstraZeneca Pharmaceuticals

Application Number

020541

Supplement Number

000

Supplement Type Code

N

Dosage Form

tablet

General Indication

breast

Line or type of therapy

Second

Specific Indication

Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy.

Subpart H-Accelerated Approval?

0

Filing Date

Mar 29 1995

Advisory Committee Date

Oct 16 1995

Advisory Committee Recommendation

Approvable: 10:0

Approval Date

Dec 27 1995

Number of Studies Reviewed

2

Study Comments

Two multicenter, randomized controlled trials comparing anastrozole (1 mg/d and 10 mg/d) and megestrol acetate (160 mg/d) in postmenopausal women with advanced breast cancer with disease progression following tamoxifen therapy.

Study Results

See individual studies. Approximately 1/3 of the patients in each treatment group in both studies had either an objective response or stabilization of their disease for greater than 24 weeks . Combined results: Response Rate Duration of Response anastrozole 1 (n=263) 10.3% (6 CR, 21 PR) 92-512+ days anastrozole 10 (n=248) 8.9% (4 CR, 18PR) 112-533 megestrol (n=253) 7.9% (5 CR, 15 PR) 111+ - 427+ None of the within trial differences were statistically significant. For time to progression: Hazard ratio (anas 1mg: meg): 0.97 [0.75-1.24] (p=0.76) Hazard ratio (anas 10mg:meg): 0.92 [0.71, 1.19] (p=0.47) For response rates: Odds ratio (anas 1:meg): 1.32 [0.66, 2.65] (p=0.37) Odds ratio (anas 10:meg): 1.15 [0.55, 2.36] (p=0.68) These data demonstrate that both anastrozole 1 mg and 10 mg were similar in efficacy to the comparator. The labeled dose is 1 mg tablet taken once a day.

Follow Up Commitments

Post-approval studies and analyses are detailed in Zeneca's 12/7/95 correspondence in response to our 12/1/95 fax. The agreements were not included in the approval letter. 1. Submit results on median response duration and median survival for patients on all treatment arms from Trials 0004 and 0005. 2. Complete ongoing Phase 3 trials in advanced breast cancer and submit study reports: -1033IL/0027 Europe -1033IL/0030 N. America -1033IL/0025 Europe