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.
Acute Myeloid Leukemia (AML) is a type of cancer that originates in the bone marrow and rapidly progresses, affecting the blood and other tissues. AML is characterized by the abnormal proliferation of myeloid cells, which are a type of white blood cell. These immature cells, known as blasts, accumulate in the bone marrow and interfere with the production of normal blood cells. This disruption leads to symptoms such as fatigue, frequent infections, easy bruising or bleeding, and anemia. AML is the most common acute leukemia in adults, with the incidence increasing with age.
The cause of AML is not fully understood, but several risk factors have been identified, including genetic mutations, previous chemotherapy or radiation therapy, exposure to certain chemicals, and smoking. Treatment typically involves intensive chemotherapy to induce remission, followed by consolidation therapy to eliminate residual disease. In some cases, a stem cell transplant may be recommended. The prognosis for AML varies based on factors such as patient age, overall health, and specific genetic mutations present in the leukemia cells.
Companion diagnostic testing plays a crucial role in the treatment of acute myeloid leukemia (AML) with TIBSOVO (ivosidenib). Specifically, it is necessary to test for the IDH1 mutation in AML patients using an FDA-approved diagnostic. This mutation must be present for TIBSOVO to be an appropriate treatment option. The test identifies patients whose leukemia cells have the IDH1 mutation, making them suitable candidates for treatment with TIBSOVO, which targets the mutant IDH1 enzyme to hinder cancer cell growth and survival.
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 designed to treat several conditions, including AML, by targeting specific genetic mutations in cancer cells.
Adults with AML who have been diagnosed with an IDH1 mutation, verified by an FDA-approved test, are eligible for treatment with TIBSOVO.
TIBSOVO works by inhibiting the mutated IDH1 enzyme, which is involved in the abnormal growth of leukemia cells, helping to reduce or halt their proliferation.
Patients may experience fatigue, joint pain, diarrhea, and differentiation syndrome, among other side effects.
TIBSOVO is administered orally in tablet form, typically once daily, based on medical advice tailored to the patient’s specific health needs.
Diagnostic testing for the IDH1 mutation ensures that TIBSOVO is used appropriately, targeting the treatment to patients who are likely to benefit from its specific action.
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.
