All-Oral Treatment Combo for AML Earns FDA Nod

Published Date: 15 May 2026

The combo, decitabine and cedazuridine tablets plus venetoclax, was approved for adults aged 75 and older and adults with comorbidities that preclude intensive induction chemotherapy.

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The oral HER2 TKI was previously given accelerated approval in the second line for the indication.

The less-intensive drug combination outperforms standard induction chemotherapy in fit patients with acute myeloid leukemia.

The accelerated approval enables an endocrine therapy switch when the ESR1 resistance mutation is detected, rather than waiting for evidence of disease progression.

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The association is driven by higher rates of death from cardiovascular disease and other cancers over 13 years.

Women with breast cancer show interest in self-injecting their medication.

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