Idhifa is used to treat adults with relapsed or refractory acute myeloid leukemia who carry a specific genetic mutation. Abbott’s RealTime IDH2 Assay is used to detect the specific mutations in a patient’s blood or marrow to learn whether they’d benefit from taking Idhifa.
The drug displayed efficacy in a clinical trial with 199 leukemia patients. After six months of treatment, 19 percent of the enrollees taking Idhifa experienced more than eight months of complete remission on average.
“Idhifa is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH2 mutation,” said Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the agency’s Office of Hematology and Oncology Products. “The use of Idhifa was associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.”
More articles on supply chain:
6 drugmakers who’ve earned orphan drug designation this year
FDA expands approval for Otsuka’s antipsychotic drug: 3 things to know
Merck warns of drug delays after ‘NotPetya’ cyberattack: 3 things to know
