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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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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

R&D In Brief: Oncology

Genta submits five-year Genasense survival data: An NDA amendment based on increased five-year survival data for relapsed or refractory chronic lymphocytic leukemia patients who responded to Genasense (oblimersen) is submitted as a complete response to FDA's December 2006 "not approvable" letter for the Bcl-2 inhibitor, Genta announces June 6, after presenting the data to ASCO on June 2. Genta had appealed the "not approvable" action, but in March was notified that its appeal had been denied. The denial, however, described a pathway forward that included, but was not limited to, showing increased long-term survival. Genta's response contains new information from a completed Phase III trial showing a significant increase in overall survival for patients with relapsed or refractory CLL who received Genasense plus chemotherapy compared with patients who received chemotherapy alone. Genta said it could not provide guidance on the likely duration of FDA's review of the NDA amendment; a typical six-month review of a major amendment would place the user fee goal date at Dec. 6 or earlier

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