Xeloda(希罗达)-----转移性乳腺癌

Generic Drug Name

capecitabine

Trade Name

Xeloda

Sponsor or Applicant

Roche

Dosage Form

tablet

General Indication

breast

Line or type of therapy

Second, Third

Specific Indication

Accel. Approv. (clinical benefit subsequently established) Treatment of metastatic breast cancer resistant to both paclitaxel and an anthracycline containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy may be contraindicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalents

Subpart H-Accelerated Approval?

1

Filing Date

Oct 30 1997

Advisory Committee Date

Mar 19 1998

Advisory Committee Recommendation

- RR of 25.6 % in 43 women with breast ca resistant to both paclitaxel and an anthracycline is evidence of therapeutic benefit (11Y-1N) and the other patients in this trial are supportive of this RR (12Y-0N) - Xeloda represents meaningful therapeutic gain for patients resistant to paclitaxel and who have received 400 mg/m2 doxo (6Y, 5N, 1A) , but not in those who only have received 240 mg?m2 doxo (0Y, 12N) - overall toxicity profile acceptable (12Y, 0N) - Xeloda should receive accel. Approval for pts with metastatic breast ca resistant to paclitaxel and an anthracycline-containing regimen (10Y, 2N) or resistant to paclitaxel and who have received >400 mg/m2 doxo (8Y, 3N, 1A), but not for pts resistant to paclitaxel and who have received standard adjuvant regimen resulting in min. cumul dose of 240 mg/m2 doxo (0Y, 11N, 1A)

Approval Date

Apr 30 1998

Number of Studies Reviewed

1

Study Comments

Accelerated approval based on response rate. 25.6 % response rate in 43 pts resistant to paclitaxel and anthracyclines. Results of other patients in trial previously treated with (but by strict definition not resistant to) anthracyclines confirm this RR. RR is surrogate endpoint in accelerated approval

Study Results

Study Details (Click on NDA or Supplement Number to view details)

NDA 020896 Supplement 000

Follow Up Commitments

- Open label randomized phase III study of capecitabine in combination of docetaxel versus docetaxel monotherapy in patients with advanced and/or metastatic breast cancer (SO14999B) - Phase II study of capecitabline in patients who have received previous treatment with paclitaxel or docetaxel for locally advanced and/or metastatic breast ca (NO15542)