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Aronex Atragen

Executive Summary

FDA notified the firm that its injectable tretinoin product for acute promyelocytic leukemia is "not approvable." A scheduled review of the drug by FDA's Oncologic Advisory Committee was previously cancelled (1"The Pink Sheet" Aug. 9, In Brief)

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Aronex Atragen

NDA amendment expected by July with data from 50 additional patients enrolled after the initial filing of the injectable tretinoin NDA for acute promyelocytic leukemia patients who are unable to take the oral form. Aronex had received a "not approvable" letter after the December 1998 NDA submission (1"The Pink Sheet" Oct. 4, 1999, In Brief). At ASCO, Aronex presented Phase II data included in the NDA. In the 75-patient trial, 56 patients were evaluable. Among newly diagnosed APL patients, complete remission rates were 87%, compared with 55% among all relapsed patients. Complete remission rates were 78% for first relapses that were oral Atragen-naive (Group 1) and 23% for second relapses or relapses that had received oral Atragen within one year (Group 2). "One-year survival was 87%, 62.5% and 23% for newly diagnosed, relapse Groups 1 and 2 patients, respectively," a study abstract states

Aronex Atragen

NDA amendment expected by July with data from 50 additional patients enrolled after the initial filing of the injectable tretinoin NDA for acute promyelocytic leukemia patients who are unable to take the oral form. Aronex had received a "not approvable" letter after the December 1998 NDA submission (1"The Pink Sheet" Oct. 4, 1999, In Brief). At ASCO, Aronex presented Phase II data included in the NDA. In the 75-patient trial, 56 patients were evaluable. Among newly diagnosed APL patients, complete remission rates were 87%, compared with 55% among all relapsed patients. Complete remission rates were 78% for first relapses that were oral Atragen-naive (Group 1) and 23% for second relapses or relapses that had received oral Atragen within one year (Group 2). "One-year survival was 87%, 62.5% and 23% for newly diagnosed, relapse Groups 1 and 2 patients, respectively," a study abstract states

Aronex Atragen

Review of injectable tretinoin by FDA's Oncologic Drugs Advisory Committee scheduled for Sept. 17 is cancelled by the agency due to "deficiencies" found by FDA in Atragen's NDA, the company announces Aug. 5

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