FDA grants priority review to ivosidenib for certain patients with acute myeloid leukemia
The FDA granted priority review to ivosidenib tablets in combination with azacitidine for previously untreated IDH1-mutated acute myeloid leukemia.
Ivosidenib (Tibsovo, Servier) — an oral IDH1 inhibitor — is 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.
A supplemental new drug application for the treatment-naive indication is based on results of the randomized phase 3 AGILE trial, which included patients with previously untreated IDH1-mutated AML.
As Healio previously reported, results showed the addition of ivosidenib to azacitidine significantly extended EFS (HR = 0.33; 95% CI, 0.16-0.69) and OS (HR = 0.44; 95% CI, 0.27-0.73).
“Tibsovo is the first therapy targeting cancer metabolism to demonstrate improved event-free survival and overall survival in combination with azacitidine in patients with previously untreated IDH1-mutated acute myeloid leukemia,” Susan Pandya, MD, vice president for clinical development and head of cancer metabolism global development oncology and immuno-oncology for Servier Pharmaceuticals, said in a company-issued press release. “With this FDA acceptance for Priority Review, we are closer to offering this critical treatment option to patients in the U.S. and we look forward to engaging with regulatory agencies around the world.”
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