FDA Grants Priority Review to Capecitabine Plus Docetaxel for Breast Cancer

July 1, 2001

The Food and Drug Administration (FDA) will conduct apriority review of the supplemental New Drug Application submitted by Roche for

The Food and Drug Administration (FDA) will conduct apriority review of the supplemental New Drug Application submitted by Roche fortwice-daily oral chemotherapy with the combination of capecitabine (Xeloda) andintravenous docetaxel (Taxotere) in patients with locally advanced and/ormetastatic breast cancer previously treated with anthracycline therapy. The FDAnotified Roche that the review of the application (submitted on March 7, 2001)will be completed in 6 months.

"The FDA’s urgency on this matter is good news for womenwho fail anthracycline therapy and need additional therapy options," saidGeorges Gemayel, vice president, National Specialty Care Business Operations, atRoche.

Phase III Study Results

Data submitted in March for the FDA’s review included theresults of a large phase III study that compared the combination of capecitabineand docetaxel in women previously treated with docetaxel alone and looked atsurvival, time to disease progression, and tumor response rate.

Median survival among women treated with the combinationcompared to docetaxel alone was 13.7 vs 11.1 months (P = .0119); time to diseaseprogression was 6.1 vs 4.2 months (P = .0001); and tumor response rate was 42% vs 30%(P = .006).

The capecitabine/docetaxel study involved 511 women and wasconducted in the United States, Canada, Australia, and countries in Europe,Asia, and Latin America. Women were randomized to either combination therapy(oral capecitabine, 1,250 mg/m2 twice daily, days 1 to 14 with 1 week of rest,plus IV docetaxel, 75 mg/m2, day 1 of each 21-day treatment cycle) ormonotherapy (IV docetaxel, 100 mg/m2, day 1 of each 21-day treatmentcycle).

Adverse Events

The combination of capecitabine and docetaxel was associatedwith more adverse events than docetaxel alone, including more diarrhea,stomatitis, hand-foot syndrome, and nausea/vomiting. These symptoms weremanageable with appropriate medical intervention and by dose interruptionsand/or reductions when needed. Patients receiving docetaxel alone experienced ahigher incidence of neutropenic fever, myalgia, and arthralgia. Thehealth-related quality of life, as assessed by a standardized questionnaire (theEuropean Organization for Research and Treatment of Cancer Quality of Life C30questionnaire), and the number of hospitalizations for treatment-related adverseevents were similar in both groups.