medwireNews: The US FDA has announced regulatory approval for the use of two agents in patients with acute myeloid leukemia (AML) and colorectal cancer (CRC) characterized by key genetic markers.
Enasidenib, an oral small molecular inhibitor of isocitrate dehydrogenase 2 (IDH2), is granted regular approval for the treatment of relapsed or refractory AML in patients with an IDH2 mutation. The FDA also approved use of a companion diagnostic test for detection of the relevant mutation.
The drug is recommended at a daily dose of 100 mg until disease progression or unacceptable toxicity. And following differentiation syndrome in 14% of patients during clinical trial, a boxed warning has been included in the prescribing information.
The FDA has also granted accelerated approval for the use of nivolumab in patients with metastatic CRC characterised by DNA mismatch repair deficiency or high microsatellite instability. The treatment may be used after disease progression on treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
The approval is based on data from the CheckMate 142 trial and, although nivolumab has not been trialled in children, the agent’s use from age 12 years onwards has been extrapolated from this study.
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