Servier has announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) for TIBSOVO® (ivosidenib tablets) in combination with azacitidine to potentially treat patients with previously untreated IDH1-mutated acute myeloid leukemia (AML). The sNDA was granted Priority Review, accelerating the review and shortening the review time goal from 10 months to 6 months. The medication is currently approved in the U.S. as monotherapy for treating adults with IDH1-mutant relapsed or refractory acute myeloid leukemia (AML) and for adults ≥75 years old newly diagnosed with IDH1-mutant AML or who have comorbidities that prevent the use of intensive induction chemotherapy. TIBSOVO was also approved recently as a first and only targeted therapy for patients with previously treated IDH1-mutated cholangiocarcinoma. TIBSOVO, in combination with azacitidine, is the first therapy targeting cancer metabolism to show improved event-free survival and overall survival in patients with previously untreated IDH1-mutated AML. Acute myeloid leukemia, cancer of the blood and bone marrow marked by rapid disease progression, is the most common acute leukemia affecting adults. Servier is a commercial-stage pharmaceutical company committed to finding solutions that will address today’s challenges in oncology, with a goal to serve patients with the utmost treatment and care to improve the potential for survival.

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