NEW YORK – Servier on Wednesday said the European Commission approved Tibsovo (ivosidenib) for two IDH1-mutated cancer indications.
The drug is now approved in the EU as a monotherapy for previously treated advanced cholangiocarcinoma patients whose cancers harbor IDH1 R132 mutations and in combination with chemotherapy for newly diagnosed acute myeloid leukemia patients whose cancers harbor IDH1 R132 mutations and who are not eligible for standard first-line therapy.
The EC's approvals follow positive opinions on these indications from the European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) in February.
In approving Tibsovo for previously treated cholangiocarcinoma patients, regulators considered data from the Phase III ClarIDHy clinical trial, in which those on Tibsovo had better median progression-free survival of 2.7 months compared to 1.4 months for patients in the placebo arm. The US Food and Drug Administration has approved Tibsovo for IDH1-mutated cholangiocarcinoma along with Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic for identifying treatment-eligible patients.
As for the AML indication, the EC considered data from the Phase III AGILE clinical trial, in which patients receiving Tibsovo plus chemotherapy lived for a median of 24 months versus 7.9 months among those who received just chemo. The IDH1 inhibitor also improved event-free survival, complete remission rates, and objective response rates.
In the US, Tibsovo is available for the same population of newly diagnosed AML patients as of May 2022.