Treatment concerns patients with IDH1-mutated acute myeloid leukaemia and IDH1-mutated cholangiocarcinoma

Servier has revealed that the European Commission (EC) has approved Tibsovo – also known as ivosidenib tablets – as a therapy in two vital indications.

The first is in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation. These individuals will not have been eligible to receive standard induction chemotherapy.

The second is as a monotherapy among adult patients with locally advanced or metastatic cholangiocarcinoma in addition to a IDH1 R132 mutation who have previously undergone treatment using at least one prior line of systemic therapy.

Tibsovo remains the only IDH1 inhibitor approved across Europe, while it has also received orphan medicine designation recognising the significant benefit brought to patients by the drug.

Philippe Gonnard, executive vice president, global product strategy at Servier, explained: “IDH1 mutations are major drivers of disease progression in AML and cholangiocarcinoma, which are usually diagnosed at an advanced stage, highlighting the urgent need for a targeted therapeutic option.”

He added: “The development of new targeted therapies such as Tibsovo, which works differently from traditional chemotherapies, is now providing treatment options that may increase the life expectancy and quality of life for patients.”

Arnaud Lallouette, executive vice president, global medical and patient affairs at Servier, commented: “The prognosis for patients diagnosed with AML or cholangiocarcinoma has historically been poor with very limited treatment options.”

He concluded: “With today’s approval by the EC, 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.”

AML is a type of cancer which impacts blood and bone marrow, and is defined by rapid disease progression. The condition is the most prevalent acute leukaemia in the adult population, affecting five out of every 100,000 people throughout Europe.

Reference：

https://www.pharmatimes.com/news/european_commission_green_lights_serviers_tibsovo_1491453