Regulatory Status Of Irinotecan Therapy

In 2005, based on cumulative evidence supporting the clinical significance of UGT1A1*28, the FDA in the United States approved a label amendment for irinotecan (Camptosar®). The amendment recommended "a reduction in the starting dose by at least one level of irinotecan for the UGT1A1*28 homozygous patients" [NDA 20-571/S-024/S-027/S-028 Camptosar (irinotecan HCl)]. However, because of the still limited scales of clinical investigations, the genetic test is not mandatory and the appropriate dose adjustment has not yet been established. Currently, clinical trials using novel SN-38 delivery systems are also underway in several countries. Because approved irinotecan-containing regimens and ethnicity vary among countries, evaluation of the effectiveness of pharmacogenetic approaches should be based on the practical status of each irinotecan-containing regimen. Further prospective studies are needed to establish safer and more effective dosing strategies for irinotecan treatment to patients with UGT1A1*28 and *6.

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