Breast Cancer

Oral Drug Data Presented That Received FDA Accelerated Approval

Published in Cancer Weekly, June 1st, 1998

Data from a phase II trial presented at the 1998 Annual Meeting of the American Society for Clinical Oncology (ASCO) showed that Xeloda (capecitabine) reduced tumor size by more than 50 percent in one out of four (11/43) patients with hard-to-treat tumors resistant to standard chemotherapy with paclitaxel and an anthracycline-containing regimen.

The data were the basis for the U.S. Food and Drug Administration's (FDA) accelerated approval of Xeloda on April 30, 1998. The product is now available in the United States.

The FDA's decision was based on a subset of 43 patients resistant to paclitaxel and an anthracycline-containing regimen; the response...

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Source: Cancer Weekly (1998-06-01)

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