Servier receives European Commission approval of Tibsovo® (ivosidenib tablets) in IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma

• Marketing Authorization granted for Tibsovo^® as the first and only approved IDH1 targeted therapy in Europe
• IDH1-mutated Acute Myeloid Leukemia and IDH1-mutated Cholangiocarcinoma, difficult and hard-to-treat cancer

PARIS, May 10, 2023 /PRNewswire/ -- Servier, a global pharmaceutical group, today announced that the European Commission (EC) has approved Tibsovo^® (ivosidenib tablets) as a targeted therapy in two indications: in combination with azacitidine for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy; as well as in monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.

Tibsovo^® is the first and only IDH1 inhibitor approved in Europe. It has received orphan medicine designation recognizing the significant benefit brought to patients by Tibsovo^® over available therapies for both CCA and AML.

"The prognosis for patients diagnosed with acute myeloid leukemia or cholangiocarcinoma has historically been poor with very limited treatment options. 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," said Arnaud Lallouette, M.D., Executive Vice President, Global Medical & Patient Affairs at Servier.

"IDH1 mutations are major drivers of disease progression in acute myeloid leukemia and cholangiocarcinoma, which are usually diagnosed at an advanced stage, highlighting the urgent need for a targeted therapeutic option. 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," said Philippe Gonnard, M.D., Executive Vice President, Global Product Strategy at Servier.

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Media contact:
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