NEW YORK – The US Food and Drug Administration on Wednesday approved Servier's Tibsovo (ivosidenib) with azacitidine chemotherapy for certain newly diagnosed, IDH1-mutated acute myeloid leukemia patients.
The FDA considered data from the Phase III AGILE trial in order to approve Tibsovo for AML patients over age of 75 or those who cannot receive intensive induction chemotherapy due to comorbidities. That trial pitted Tibsovo and chemo against chemo and placebo in 148 patients with newly diagnosed AML.
The Tibsovo-chemo combination improved both event-free survival and overall survival compared to chemo alone. Patients treated with Tibsovo and chemo lived for a median of 24 months, whereas patients on just chemo lived a median of 7.9 months.
Between 6 percent and 10 percent of AML patients harbor IDH1 mutations. Tibsovo monotherapy is already approved in the US for patients with IDH1-mutant relapsed or refractory AML as well as for patients with newly diagnosed IDH1-mutated AML who are at least 75 years old or who cannot receive intensive induction chemo. The agent is also approved for previously treated cholangiocarcinoma patients whose tumors harbor IDH1 mutations.
Agios Pharmaceuticals owned Tibsovo until late 2020, when the firm sold its entire oncology portfolio to Servier.