FDA approves ivosidenib plus azacitidine for certain patients with acute myeloid leukemia
The FDA approved ivosidenib tablets in combination with azacitidine for previously untreated IDH1-mutated acute myeloid leukemia.
Ivosidenib (Tibsovo, Servier) — an oral IDH1 inhibitor — had been approved in the United States for treatment of adults with relapsed or refractory IDH1 mutation-positive AML, as well as for adults with newly diagnosed IDH1 mutation-positive AML who are aged 75 years or older or who are ineligible for intensive induction chemotherapy due to comorbidities.
The agent also is approved for adults with previously treated, locally advanced or metastatic IDH1-mutated cholangiocarcinoma.
The FDA based the approval of the treatment-naive indication on results of the randomized phase 3 AGILE trial, which included 146 patients with previously untreated IDH1-mutated AML.
Results showed the addition of ivosidenib to azacitidine significantly extended EFS (HR = 0.35; 95% CI, 0.17-0.72) and OS (median, 24 months vs. 7.9 months; HR = 0.44; 95% CI, 0.27-0.73), according to a Servier press release.
The combination had a safety profile consistent with previous reports. The most common adverse events included nausea, vomiting, prolonged QT interval on ECG, insomnia, differentiation syndrome, leukocytosis, hematoma, hypertension, arthralgia, dyspnea and headache.
“In addition to a favorable safety profile, Tibsovo is the first therapy targeting cancer metabolism to demonstrate an impressive, significant benefit in event-free survival and overall survival in combination with azacitidine, underscoring its importance as part of a new combination regimen for patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are not candidates for intensive induction chemotherapy,” Eytan M. Stein, MD, director of the program for drug development in leukemia in the leukemia service at Memorial Sloan Kettering Cancer Center, said in the release.
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