NEW YORK – Servier on Monday said that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion on Tibsovo (ivosidenib) for IDH1-mutated acute myeloid leukemia and cholangiocarcinoma.
Servier is seeking approval of Tibsovo with azacitidine for patients with newly diagnosed IDH1-mutated acute myeloid leukemia who are not eligible for standard induction chemotherapy and for patients with locally advanced or metastatic IDH-1 mutated cholangiocarcinoma that have previously been treated with at least one systemic therapy. The positive opinion will now be referred with a recommendation for approval to the European Commission, which is expected to make a decision within months. It will cover all 27 EU member states plus Iceland, Norway, Northern Ireland, and Liechtenstein.
For the AML indication, CHMP's opinion was based on the Phase III AGILE trial, which compared Tibsovo and azacitidine to placebo and azacitidine in 148 patients with newly diagnosed AML. The patients in the Tibsovo-azacitidine group had improved event-free survival and overall survival compared to those receiving just azacitidine and lived for a median of 24 months compared to 7.9 months for the azacitidine group. The US Food and Drug Administration approved Tibsovo in this setting in May 2022.
The decision in bile duct cancer was based on the Phase III ClarIDHy trial which found an improvement in overall survival compared to placebo for patients with chemotherapy-refractory IDH1-mutated cholangiocarcinoma.
The FDA has also approved Tibsovo as a treatment for IDH1-mutated cholangiocarcinoma with Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic to identify patients whose cancers bear an IDH1 mutation.