Tibsovo is an isocitrate dehydrogenase-1 inhibitor designed to treat IDH1 R132-mutated locally advanced or metastatic cholangiocarcinoma in adult patients who have been previously treated by at least one prior line of systemic therapy.
As well as azacytidine, the therapy can treat newly diagnosed IDH1 R132-mutated AML adult patients who are not eligible to receive standard induction chemotherapy.
According to Servier, Tibsovo is the first and only IDH1 inhibitor to receive approval in Europe.
"The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options,” said Arnaud Lallouette, executive vice president, global medical & patient affairs at Servier.
“With today's approval by the European Commission, Tibsovo is now the first targeted IDH1 inhibitor approved in Europe. This further affirms our unparalleled scientific leadership in harnessing the IDH mutation and commitment to finding new therapeutic solutions for patients with difficult and hard-to-treat cancers.”
The approval by the EC in AML is supported by data from the AGILE study, a global phase 3 multicentre, double-blind, randomized, placebo-controlled clinical trial published in the New England Journal of Medicine.
In addition, the regulatory approval for Tibsovo to treat cholangiocarcinoma was supported by the data obtained from the ClarIDHy phase 3 trial.
Tibsovo is approved in the US as monotherapy to treat IDH1-mutant relapsed or refractory AML in adult patients.