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Additional Ceplene trial needed

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's request for another Phase III trial for Maxim's Ceplene for acute myeloid leukemia means the company will need a corporate partner, the firm says Jan. 18. The immunomodulator met the primary endpoint of leukemia-free survival in combination with interleukin-2 in the prior 320-patient Phase III study. Maxim withdrew its first NDA for Ceplene, for malignant melanoma (1Pharmaceutical Approvals Monthly Nov. 1, 2004, In Brief). Maxim remains in discussions with FDA regarding trial design, and is discussing the need for another AML trial with European regulators...
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