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R&D IN BRIEF

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

More unappealing Genasense news for Genta: Genta's long campaign for approval of its oncologic Genasense (oblimersen) hit another roadblock with the failure of the company's appeal of a Dec. 3, 2008 "complete response" letter. The center-level appeal failed to overturn the Office of Oncology Drug Product's conclusion that approval of the drug in chronic lymphocytic leukemia would require an additional confirmatory trial (1Pharmaceutical Approvals Monthly December 2008, In Brief). Genta has been pursuing CDER's dispute resolution process since receiving a "not approvable" letter in December 2006, contesting FDA's preference for progression-free survival over the composite endpoint used in the pivotal CLL trial. Genta made some headway in early 2008, when FDA denied the appeal but accepted complete response as an appropriate endpoint. The company proceeded to file an amended NDA with five-year follow-up data from the original Phase III trial. Genta reported that after five years, "all patients who achieved a major response (either complete or partial remission) on the Genasense treatment arm achieved superior survival compared with responders treated with chemotherapy alone." Nonetheless, "CDER concluded that new information submitted by the company in its amended [NDA] was insufficient, and the agency has recommended conducting a confirmatory clinical trial," Genta stated March 6. "While disappointed with this decision, we appreciate FDA's clarification of the path to U.S. regulatory approval." With the CLL indication stalled, Genta has been talking up use of Genasense in advanced melanoma. It expects final PFS data from the AGENDA trial in the second half of the year, with NDA submission targeted by year-end
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