US approves first-in-class targeted AML therapy
US regulators have approved the first targeted therapy for patients with relapsed or refractory acute myeloid leukemia carrying a certain genetic mutation.
Agios Pharmaceuticals’ Tibsovo (ivosidenib) is the first drug in the isocitrate dehydrogenase-1 (IDH1) inhibitor class of medicines to win a green light, and has been approved with a companion diagnostic able to detect specific mutations in the IDH1 gene in patients with the disease.
“Tibsovo is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH1 mutation,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.”
Read more: http://www.pharmatimes.com/news/us_approves_first-in-class_targeted_aml_therapy_1245302
Agios Pharmaceuticals’ Tibsovo (ivosidenib) is the first drug in the isocitrate dehydrogenase-1 (IDH1) inhibitor class of medicines to win a green light, and has been approved with a companion diagnostic able to detect specific mutations in the IDH1 gene in patients with the disease.
“Tibsovo is a targeted therapy that fills an unmet need for patients with relapsed or refractory AML who have an IDH1 mutation,” said Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.
“The use of Tibsovo is associated with a complete remission in some patients and a reduction in the need for both red cell and platelet transfusions.”
Read more: http://www.pharmatimes.com/news/us_approves_first-in-class_targeted_aml_therapy_1245302