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.
Myelodysplastic syndromes (MDS) are a group of diverse bone marrow disorders in which the bone marrow does not produce enough healthy blood cells. These syndromes are characterized by the ineffective production (dysplasia) of myeloid cells, which can lead to anemia, infection risk, and bleeding. MDS can affect any of the blood cell types, including red cells, white cells, and platelets. This condition primarily affects older adults and can evolve into acute myeloid leukemia (AML) in some cases. The specific cause of MDS is often unclear, but it can be linked to genetic mutations and previous chemotherapy or radiation therapy. Treatment options vary based on the severity and type of blood cell affected and may include supportive care, drug therapy, or bone marrow transplantation.
Companion diagnostic testing plays a critical role in the decision to treat myelodysplastic syndromes (MDS) with TIBSOVO. Specifically, patients eligible for treatment need to have their cancer cells tested for an IDH1 mutation. The presence of this mutation can be determined using an FDA-approved test. This genetic testing ensures that TIBSOVO, which targets the IDH1 mutation, is used for patients who are most likely to benefit from this specific mechanism of action, enhancing the precision and effectiveness of the treatment.
This companion diagnostic was developed by an IVD manufacturer as a kit. This is a valid FDA approved test if utilized by 3rd party diagnostic labs who have validated the test using the kit on the specified platform. It is not directly orderable from the manufacturer.
TIBSOVO (ivosidenib) is an oral medication used to treat certain types of myelodysplastic syndromes (MDS), specifically targeting cells with an IDH1 mutation.
Adult patients with MDS who have an IDH1 mutation, as detected by an FDA-approved diagnostic test, are eligible for treatment with TIBSOVO.
TIBSOVO inhibits the mutated IDH1 enzyme, which is involved in the metabolic pathways of cancer cells. By targeting this pathway, TIBSOVO can reduce the abnormal proliferation of bone marrow cells.
Common side effects for MDS patients taking TIBSOVO include fatigue, joint pain, and gastrointestinal symptoms such as nausea and diarrhea.
TIBSOVO is taken orally, once daily, and the specific dosage may vary based on the patient’s medical condition and response to the treatment.
Before starting treatment, it’s crucial to confirm the presence of an IDH1 mutation in the patient’s MDS cells through FDA-approved testing. This ensures that TIBSOVO is prescribed appropriately, targeting the specific genetic mutation for optimal treatment outcomes.
Servier is a global leader in oncology focused on delivering meaningful therapeutic progress for the patients it serves. Governed by a non-profit foundation, Servier approaches innovation with a long-term vision, free of influence from investors and outside pressure to chase short-term monetary targets.
As a leader in oncology, Servier has significantly accelerated its investment in difficult and hard-to-treat cancers, with more than 50% of its research and development dedicated to delivering significant advances in areas of high unmet need throughout oncology with the potential to change the lives of the patients it serves. Within these areas, Servier is the leader in mutant IDH inhibition, with the first ever mutant IDH1 inhibitor approved in the U.S. and the European Union, and the company continues to drive the science behind targeted mutant IDH inhibition.
Servier’s commitment to therapeutic progress guides its collaboration strategy. While many companies across the industry are scaling back investments, Servier is actively building alliances, completing acquisitions, conducting licensing deals and entering new partnerships that can help to accelerate access to therapies for patients in need. With the company’s commercial expertise, global reach, scientific expertise and commitment to clinical excellence, Servier is dedicated to bringing the promise of tomorrow to the patients it serves.
