FRIDAY, July 20, 2018 — Tibsovo (ivosidenib) tablets have been approved by the U.S. Food and Drug Administration to treat relapsed or refractory acute myeloid leukemia (AML) among people with a defective IDH1 gene.

“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,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence.

AML, a rapidly-progressing cancer that forms in the bone marrow, leads to increasing numbers of abnormal white blood cells, the agency said in a news release. More than 19,000 people in the United States are likely to be diagnosed with AML this year, and more than 10,000 are projected to die of it, the National Cancer Institute estimates.

Tibsovo’s effectiveness was clinically studied among 174 adults with AML who had the defective IDH1 gene. The most common side effects of the drug included fatigue, an increase in white blood cells, joint pain, diarrhea, shortness of breath, swelling of the arms and legs, and mouth sores.

Because it could harm a newborn baby, women who are breastfeeding shouldn’t take Tibsovo, the FDA said.

The drug’s label includes the agency’s most serious boxed warning of a condition called differentiation syndrome, characterized by possible symptoms including fever, difficulty breathing, lung inflammation, fluid surrounding the heart or heart, rapid weight gain, swelling and multi-organ dysfunction.

Other possible serious side effects include conditions called QT prolongation and Guillain-Barré syndrome, the agency said.

Tibsovo is produced by Massachusetts-based Agios Pharmaceuticals.

The FDA said it simultaneously approved a new diagnostic to detect cases of AML caused by the defective gene. The new test is produced by Abbott Laboratories.

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Posted: July 2018

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