Roche Xeloda (correction)
Xeloda (capecitabine) labeling recommends a dose reduction in patients with moderate renal impairment; the agent is contraindicated in patients with severe renal impairment. In a story on the approval of the Roche drug for combination use in metastatic breast cancer, "The Pink Sheet" (Sept. 17, p. 13) incorrectly said that moderate renal impairment is a contraindication. Roche notes that the sNDA for Xeloda included a very small number of locally advanced breast cancer patients (11 out of 511). "The number of patients...was too small to reach conclusions. It is not that FDA did not approve this indication," company explains. In a companion story about a new boxed warning in Xeloda labeling (p. 14), a statement attributed to Roche was incorrect. The company noted that many other drugs interact with warfarin
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