IDHIFA (enasidenib) is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA-approved test. IDHIFA is developed by Agios Pharmaceuticals in collaboration with Celgene Corporation. Agios is focused on discovering and developing novel investigational medicines to treat cancer and rare genetic diseases through scientific leadership in the field of cellular metabolism.
REZLIDHIA (olutasidenib) is an oral medication designed to treat acute myeloid leukemia (AML) in adults with a specific genetic mutation known as an IDH1 mutation. This drug is particularly used for patients whose disease has relapsed or who have not responded to other treatments. REZLIDHIA works by inhibiting the IDH1 enzyme, which in its mutated form contributes to the growth and survival of cancer cells. By targeting this enzyme, REZLIDHIA helps to reduce the production of an oncometabolite that promotes cancer cell growth, thereby aiding in the differentiation of cells and potentially leading to the restoration of normal blood cell function. This targeted approach offers a treatment option that can be critical for patients with this challenging form of leukemia who have limited treatment options.
RYDAPT® (midostaurin) is an oral medication designed to inhibit multiple kinase enzymes, including FLT3 and KIT, which are essential for the growth and survival of certain cancer cells. Approved for use in adult patients, RYDAPT is indicated for the treatment of newly diagnosed acute myeloid leukemia (AML) that is FLT3 mutation-positive, in conjunction with standard chemotherapy. Additionally, RYDAPT is the first and only treatment approved for adult patients with advanced systemic mastocytosis, including aggressive systemic mastocytosis, systemic mastocytosis with associated hematological neoplasm, and mast cell leukemia. This approval marks a significant advancement in targeting complex blood cancers and provides a critical therapeutic option for conditions that previously had limited treatment avenues.
TIBSOVO is a precision medicine that targets a specific type of mutation known as isocitrate dehydrogenase 1 (IDH1). TIBSOVO is approved in five indications globally, including approvals in the U.S., European Union, Australia, and China.
In the U.S., TIBSOVO is approved for the treatment of adults with IDH1-mutant relapsed or refractory AML and in monotherapy or in combination with azacitidine for adults with newly diagnosed IDH1-mutant AML who are ≥75 years old or who have comorbidities that preclude the use of intensive induction chemotherapy, as monotherapy for the treatment of adult patients with IDH1-mutant relapsed or refractory MDS, and for patients with previously treated IDH1-mutated cholangiocarcinoma.
Servier has granted CStone a co-exclusive license for the development and an exclusive license agreement for the commercialization of TIBSOVO in Mainland China, Taiwan, Hong Kong, Macao and Singapore.
