TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast Cancer Oncologic Drugs Advisory Committee TAXOL® (paclitaxel) for Adjuvant Treatment of Node Positive Breast Cancer Oncologic Drugs Advisory Committee CONCLUDING REMARKS Renzo Canetta, M.D. Bristol-Myers Squibb Company Pharmaceutical Research Institute Wallingford, Connecticut

CONCLUSIONS The pivotal study is the largest trial of chemotherapy in the adjuvant treatment of node positive breast cancer ever submitted to FDA The comparison of TAXOL versus no further therapy demonstrates a significant advantage in clinically meaningful endpoints (both DFS and survival) Administration of TAXOL after standard therapy produces a low incidence of additional toxicity, consistent with the safety profile of the dose adopted

PROPOSED INDICATION TAXOL® (paclitaxel) administered sequential to standard combination therapy is indicated for the adjuvant treatment of node positive breast cancer

PROPOSED DOSE AND SCHEDULE TAXOL® (paclitaxel) in this setting should be administered at a dose of 175 mg/m 2 intravenously over three hours every three weeks for four courses