Skip to Main Content

Advertisement

Skip Nav Destination

FDA Grants Priority Review of Enasidenib for Acute Myeloid Leukemia

December 30, 2021

The FDA granted priority review of enasidenib for patients with relapsed/refractory IDH2-mutated acute myeloid leukemia (AML).

The decision was based on results of the single-arm, phase I/II AG221-C-001 study, which included 198 patients (median age = 69 years) with relapsed/refractory AML (70%), untreated AML (17%), myelodysplastic syndromes (7%), or another IDH2-mutant hematologic malignancy (6%).

Patients received a median of two prior therapies (range = 1-6 therapies), and 64 percent received ≥2 prior therapies. Enasidenib was administered at escalating doses, increasing from 30 mg or 50 mg once or twice daily to the highest dose of 450 mg daily. Though a maximum tolerated dose was not reached, the dose selected for future studies was 100 mg once daily.

Among 181 evaluable patients (including 128 with relapsed/refractory AML), the objective response rate was 41 percent in enasidenib-treated patients. The complete response (CR) rate was 18 percent, with 1.6 percent of patients achieving a CR with incomplete platelet recovery or incomplete blood count recovery. Fourteen percent of patients had a partial response (PR).

The median duration of response was 6.9 months; in those with relapsed/refractory AML, the median duration was six months (95% CI 3.7-9.2).

Overall, eight patients went on to receive HCT, five of whom had relapsed/refractory AML. The most common treatment-related AEs were indirect hyperbilirubinemia (19%) and nausea (18%).

Source: Celgene press release, March 1, 2017.

Advertisement

Connect with us:

CURRENT ISSUE
August 2022

Advertisement

Close Modal

or Create an Account

Close Modal
Close Modal

Advertisement

X