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capecitabine [Xeloda]

Phase 3
Roche Holding AG (RHHBY)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

1

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Drug Information

Target Indication

Colorectal Cancer

Clinical Trial

NCT01227707

Last updated: 1/28/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMA2/2/2001

Xeloda

Xeloda is indicated for the adjuvant treatment of patients following surgery of stage III (Dukes' stage C) colon cancer. Xeloda is indicated for the treatment of metastatic colorectal cancer. Xeloda is indicated for first-line treatment of advanced gastric cancer in combination with a platinum-based regimen. Xeloda in combination with docetaxel is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Xeloda is also indicated as monotherapy for the treatment of patients with locally advanced or metastatic breast cancer after failure of taxanes and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.

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Mechanism of action & safety profile
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