NUTLEY, NJ--Hoffmann-La Roche Inc. has received accelerated approval from the Food and Drug Administration for Xeloda (capecitabine), making it the first approved oral anticancer drug for patients with metastatic breast cancer whose tumors are resistant to standard chemotherapy with paclitaxel(Drug information on paclitaxel) (Taxol) and an anthracycline-containing regimen.
"Xeloda is a significant advance in the treatment of metastatic breast cancer," said Linda Vahdat, MD, assistant professor of medicine and director of the Autologous Transplant Program for Breast Cancer, Columbia-Presbyterian Medical Center, New York. "At last, patients can take an effective pill, in their homes, to treat their cancer."
Xelodas pivotal phase II multicenter trial involved 162 patients with metastatic breast cancer. The FDAs decision was based on a subset of 43 patients resistant to paclitaxel and an anthracycline-containing regimen; the response rate in these patients was 25.6%. Overall, 18.5% of patients experienced a reduction in tumor size of more than 50%, and a single patient had a complete remission. As a condition of accelerated approval, the company is conducting ongoing studies to confirm these clinical outcomes.
Xeloda caused minimal hair loss and limited bone marrow depression in the phase II study, the company said. The most frequently reported side effects included diarrhea, nausea and vomiting, stomatitis, fatigue, and hand-foot syndrome, but these were generally manageable and reversible after dosage adjustment.
However, Xeloda was associated with serious risks such as severe diarrhea (which was greater in patients older than age 80) and some grade 3/4 neutropenia (4%), thrombocytopenia (2%), and decreases in hemoglobin (3%).