Genasense chronic leukemia NDA gets rolling

Executive Summary

Genta has initiated a rolling NDA for use of Genasense (oblimersen) in combination with fludarabine and cyclophosphamide in fludarabine-experienced chronic lymphocytic leukemia patients, the firm says June 30. Genta expects to complete the submission within six months. The company previously indicated it would initiate a confirmatory CLL study for accelerated approval before year-end (1Pharmaceutical Approvals Monthly June 2005, p. 3); the company says it "plans to discuss the design of that study with FDA." The CLL NDA will include a Phase I/II study of Genasense alone in relapsed/refractory CLL and a Phase III study of Genasense in combination with the flu/cy regimen versus fly/cy alone. The latter study showed a significant benefit for complete response, but Genta said overall survival "is too early to analyze"...