Genta appeals FDA’s Genasense ruling – again
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Once again, Genta is appealing FDA's decision to issue an action letter for Genasense (oblimersen). The firm announced Dec. 11 it was appealing FDA's Dec. 3 "complete response" letter for the injectable chronic lymphocytic leukemia treatment. The letter requests another trial be conducted. In July, Genta submitted five-year follow-up data from the original pivotal Phase III trial in an amended NDA, after unsuccessfully appealing a "not approvable" letter it received in 2006 (1Pharmaceutical Approvals Monthly June 2008, p. 21). Genta said it "looks forward to promptly meeting with senior FDA leadership to formally review the key issues" of the NDA
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Once again, Genta is appealing FDA's decision to issue an action letter for Genasense (oblimersen). The firm announced Dec. 11 it was appealing FDA's Dec. 3 "complete response" letter for the injectable chronic lymphocytic leukemia treatment. The letter requests another trial be conducted. In July, Genta submitted five-year follow-up data from the original pivotal Phase III trial in an amended NDA, after unsuccessfully appealing a "not approvable" letter it received in 2006 (1 Pharmaceutical Approvals Monthly June 2008, p. 21). Genta said it "looks forward to promptly meeting with senior FDA leadership to formally review the key issues" of the NDA. |