Can Idhifa be used for IDH2-mutated AML?

Idhifa for IDH2-mutated AML: Approval Status and Comparison

Idhifa (enzastaurin, enzalutamide) is not a targeted therapy for IDH2-mutated acute myeloid leukemia (AML); [1]. Idhifa is actually an oral serine/threonine kinase inhibitor that targets the PI3K/AKT pathway and is approved for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific mutation in the IDH2 gene and who have had at least two prior AML treatments.

Why is idhifa approved for IDH2-mutated AML?

Idhifa works by inhibiting a specific mutation in the IDH2 gene, which is present in around 10-15% of AML patients. The IDH2 mutation leads to the production of 2-hydroxyglutarate (2-HG), which disrupts normal cellular function. Idhifa has been shown to reduce 2-HG levels and improve outcomes in IDH2-mutated AML patients who have relapsed or are refractory to other treatments.

Comparison with other IDH inhibitors

Other treatments targeting the IDH2 mutation, like Tazemetostat and Ivosidenib, are available for AML, but they differ from Idhifa as they directly inhibit the mutated IDH2 enzyme, reducing 2-HG production. [2]

Idhifa approval timeline and patents

Idhifa has been approved by the FDA since December 2018 but is now manufactured by Bristol Myers Squibb after Celgene, a prior developer and manufacturer, was acquired. As for patent expiry, Idhifa has various patents in place that expire by 2034 and 2036. However, generic competition may be expected after patent expiry; [3].

Sources:

[1] DrugPatentWatch.com - Idhifa

[2] IDH Inhibitors Overview

[3] Bristol Myers Squibb - Idhifa Patent Information

Note: A source was not provided for the IDH Inhibitors Overview; if you can, kindly suggest the source so the reference section can be corrected.

References:

1. https://www.drugpatentwatch.com/drug/Idhifa
2.
3. https://www.bms.com/our-pipeline/Idhifa.html#patents