Questions About Cancer? 1-800-4-CANCER

FDA Approval for Capecitabine

Brand name(s): Xeloda®

  • Approved for Dukes' stage C colon cancer

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On June 15, 2005, the U.S. Food and Drug Administration approved capecitabine (Xeloda® Tablets, made by Hoffman-LaRoche Inc.) as a single-agent adjuvant treatment for Dukes' stage C colon cancer patients who have undergone complete resection of the primary tumor in those instances when fluoropyrimidine therapy alone would be preferred.

Dukes’ stage C colon cancer is when the cancer has spread outside the colon to one or more lymph nodes; also called stage III colon cancer.

Approval is based on non-inferiority in disease-free survival (DFS) to bolus 5-fluorouracil plus leucovorin (5-FU/LV). In 2004, the FDA approved oxaliplatin for injection (Eloxatin™) in combination with infusional 5-FU/LV for adjuvant stage III colon cancer. Although neither capecitabine nor the combination of oxaliplatin plus 5-FU/LV prolonged overall survival in the adjuvant setting, the combination chemotherapy regimen was associated with an improvement in DFS compared to 5-FU/LV in stage III colon cancer. Physicians should consider these results when prescribing single-agent capecitabine in the adjuvant treatment of Dukes' C colon cancer.

Safety and efficacy for capecitabine in the adjuvant indication were demonstrated in one multicenter, randomized, open-label, international clinical trial. There were 1987 patients with stage C colon cancer who had undergone complete resection of the primary tumor. The patients were equally randomized to one of two arms: capecitabine (1250 mg/m2 twice daily for 14 days followed by seven days rest, repeated every 21 days for eight cycles) or bolus 5-FU/LV (Mayo Clinic regimen).

At a median follow-up of 4.4 years, a non-inferiority analysis for the primary endpoint of DFS in the all randomized population showed capecitabine retained at least 75 percent of the active control effect of 5-FU/LV. The three-year DFS rates for capecitabine and 5-FU/LV were 66 percent and 63 percent, respectively (hazard ratio 0.87, 95 percent CI: 0.76-1.00; test for difference: p = 0.055). No statistical difference in overall survival was shown between the treatment arms in the all randomized population (hazard ratio 0.88, 95 percent CI: 0.74-1.05; p = 0.17).

The incidence of grade 3 or 4 adverse events was 36 percent on the capecitabine arm and 35 percent on the 5-FU/LV arm. The most common capecitabine toxicities (diarrhea, stomatitis, nausea, and palmar-plantar erythrodysesthesia) are described in the current label, and in 93 percent of cases were reversible within 30 days. The incidence of febrile neutropenia or neutropenic sepsis was less than 1 percent.

This summary was provided by Richard Pazdur, M.D., director of the FDA's Division of Oncology Drug Products.

The FDA is the division of the U.S. Department of Health and Human Services charged with ensuring the safety and effectiveness of new drugs and other products. (See "Learn How Drugs and Devices Get Approved.") The FDA's mission is to promote and protect the public health by helping safe and effective products to reach the market in a timely way, and monitoring products for continued safety after they are in use.

  • Updated: July 2, 2013