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.
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 diagnostics play a crucial role in the decision to prescribe IDHIFA (enasidenib) for patients with Acute Myeloid Leukemia (AML). IDHIFA is specifically indicated for the treatment of adult patients with relapsed or refractory AML who have a mutation in the isocitrate dehydrogenase-2 (IDH2) enzyme. The presence of this mutation must be confirmed by an FDA-approved companion diagnostic test before initiating 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.
IDHIFA (enasidenib) is used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have an isocitrate dehydrogenase-2 (IDH2) mutation, as detected by an FDA-approved test. It is an oral medication that specifically targets and inhibits the mutant IDH2 enzyme, helping to restore normal cell differentiation and reduce leukemic cells.
IDHIFA works by inhibiting the mutated IDH2 enzyme in cancer cells. This enzyme mutation is responsible for blocking the normal differentiation of myeloid cells, leading to an accumulation of immature cells. By inhibiting this enzyme, IDHIFA helps to restore the differentiation of these cells, reducing the number of leukemic cells in the bone marrow and blood.
The most common side effects of IDHIFA include nausea, vomiting, diarrhea, elevated bilirubin levels, and decreased appetite. Serious side effects can include differentiation syndrome, which may be life-threatening if not treated promptly, and other severe reactions like leukocytosis and tumor lysis syndrome.
Differentiation syndrome is a potentially life-threatening condition that can occur with IDHIFA treatment. It is characterized by symptoms such as fever, dyspnea, rapid weight gain, and fluid accumulation. Management involves prompt initiation of corticosteroids and supportive care to control symptoms and prevent severe complications.
IDHIFA is not recommended for use in pregnant women due to the risk of fetal harm. Patients with known hypersensitivity to enasidenib or any of its components should also avoid taking IDHIFA. It is important to discuss your complete medical history with your healthcare provider to determine if IDHIFA is safe for you.
IDHIFA is taken orally, with a recommended starting dose of 100 mg once daily. It is important to take IDHIFA exactly as prescribed by your healthcare provider, and dosage adjustments may be necessary based on your response and any side effects experienced. Regular monitoring by your healthcare provider is essential to ensure the effectiveness and safety of the treatment.
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
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.
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