FDA Approval Summary: Oral Azacitidine for Continued Treatment of Adults with Acute Myeloid Leukemia Unable to Complete Intensive Curative Therapy.

Autor:	Jen EY; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Wang X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li M; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Lee SL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ni N; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Przepiorka D; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Vallejo J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Leong R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Ma L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gehrke BJ; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., McLamore S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Theoret MR; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., de Claro RA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2022 Jul 15; Vol. 28 (14), pp. 2989-2993.
DOI:	10.1158/1078-0432.CCR-21-4525
Abstrakt:	On September 1, 2020, the FDA granted approval for oral azacitidine (Onureg, CC-486) for continued treatment of adult patients with acute myeloid leukemia (AML) who achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and who are not able to complete intensive curative therapy. Approval was based on improvement in overall survival using CC-486 300 mg daily in a 2 weeks on/2 weeks off schedule in comparison with placebo (HR, 0.69; 95% confidence interval, 0.55-0.86; P = 0.0009) in the randomized trial CC-486-AML-001 (QUAZAR) in adults ≥ 55 years old with AML in CR/CRi who did not complete standard intensive induction and postremission therapy. Of note, the study was not designed to test CC-486 as maintenance after standard postremission therapy or as an alternative to standard postremission therapy. Gastrointestinal toxicities, fatigue, and pneumonia were more common in patients treated with CC-486 compared with placebo. Additional studies are needed to establish safe dosing for patients with hepatic impairment. The pharmacokinetic parameters, recommended dose, and recommended schedule of CC-486 differ substantially from those of other azacitidine formulations; therefore, inappropriate substitutions between formulations pose a considerable risk for harm. (©2022 American Association for Cancer Research.)
Databáze:	MEDLINE
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