FDA Clears Roche Oral Chemotherapy For Colorectal Cancer
NUTLEY, N.J. -- The U.S. Food and Drug Administration has approved Hoffman-La Roche Inc.'s Xeloda (capecitabine) oral chemotherapy for the treatment of metastatic colorectal cancer, the second leading cause of cancer deaths among Americans.
The company said in a press release Tuesday that the FDA decision was based on the results of two multinational phase III clinical trials in metastatic colorectal cancer that demonstrate that Xeloda shrinks tumors better than a standard of care intravenous fluorouracil (5-FU) and leucovorin (LV), known as the Mayo Regimen. Xeloda requires only two daily oral doses compared to other more complex intravenous chemotherapy regimens.
Xeloda is indicated as a first-line treatment of patients with metastatic colorectal cancer when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to
5-FU/LV alone.
A survival benefit has not been demonstrated with Xeloda alone as with the combination chemotherapy, Roche said. Use of Xeloda instead of 5-FU/LV combinations has not been adequately studied to assure safety or preservation of the survival advantage.
Xeloda is covered by Medicare.
The trials included 1,200 patients and were conducted globally at 120 hospitals and cancer centers. About half the patients received Xeloda at 1,250 mg/m(2) twice daily for two weeks, followed by a one-week rest period. The other half received treatment with the Mayo Regimen.
In one of the trials, the overall response rate for Xeloda was almost double that of the Mayo Regimen (21% vs. 11%); in the other study, the overall response rate for Xeloda was 21% compared with 14% for the intravenous 5-FU + LV. Median survival was 404 days for Xeloda and 369 days for 5-FU/LV in one study and 380 days for Xeloda and 407 days for 5-FU/LV in the other.
Xeloda is not indicated in patients with severe renal impairment and those with hypersensitivity to 5-fluorouracil. Patients with moderate and mild renal impairment may warrant dose reduction, Roche said.
As with any cancer therapy, there is a risk of side effects, but Roche said these are usually manageable and reversible with dose modification or interruption. The most common adverse events are diarrhea, nausea, vomiting, stomatitis, abdominal pain, upset stomach, constipation, loss of appetite and dehydration.
Hoffman-La Roche is the U.S. prescription drug unit of the Swiss-based Roche Group healthcare giant.
Company Web site: rocheusa.com |
