Roche Files First NDA For Capecitabine

Roche has filed for approval in the USA and the European Union forXeloda (capecitabine; formerly Ro 09-1978), described by the company as the first orally-available, tumor-activated anticancer drug. The drug is also the first in a new class of anticancer agents called the fluoropyrimidine carbamates.

The company is seeking to market capecitabine for the treatment of patients with locally-advanced or metastatic breast cancer who have already failed at least one chemotherapeutic regimen including Bristol-Myers Squibb's Taxol (paclitaxel) and an anthracycline (eg doxorubicin).

Fast-Track Sought Roche says it is seeking an expedited review of the application under the fast-track procedure, which allows drugs with an urgent medical need, including anticancer drugs, to be approved on the basis of Phase II studies, and to be made available while Phase III trials are ongoing. The company notes that it has conducted a large, 162-patient Phase II study which showed a 20% objective response rate (a reduction in tumor size of at least 50%) with capecitabine. Three patients in the trial experienced complete remissions. The trial, a single-arm study, involved dosing capecitabine at 2,500mg/m2, twice-daily for two weeks, followed by one week off the drug.