The U.S. Food and Drug Administration approved Servier Pharmaceuticals LLC’s Tibsovo (ivosidenib) to treat rare form of blood cancers called relapsed or refractory or R/R Myelodysplastic Syndromes.
This is the first targeted therapy approved for this indication of R/R myelodysplastic syndromes or MDS with an isocitrate dehydrogenase-1 (IDH1) mutation.
The agency also approved the Abbott Laboratories’ RealTime IDH1 Assay as a companion diagnostic for the selection of R/R MDS patients with an IDH1 mutation.
MDS are a rare form of blood cancers that can occur when the mutations in the bone marrow progenitor cells, i.e., cells that form blood, lead to insufficient numbers of healthy blood cells.
In the U.S., around 60,000 to 170,000 people live with MDS, while worldwide, it is estimated to be 87,000 new cases each year. About 3.6 percent of patients with MDS have an IDH1 mutation.
Tibsovo’s effectiveness for this new indication was evaluated in an open-label, single-arm, multicenter study of 18 adult patients with relapsed or refractory MDS with an IDH1 mutation.
The FDA noted that IDH1 mutations were detected in peripheral blood or bone marrow by a local or central diagnostic test and confirmed retrospectively using the Abbott RealTime IDH1 Assay. Tibsovo was given orally at a starting dose of 500 milligram daily continuous for 28-day cycles until disease progression, development of unacceptable toxicity or undergoing bone marrow transplantation.
Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said, “Today’s approval represents an important treatment advancement for rare blood cancers, and more specifically, patients with relapsed or refractory MDS who have an IDH1 mutation. Through the FDA’s Oncology Center of Excellence Rare Cancers Program, we remain committed to promoting scientific innovation and advancing the development of safe and effective novel therapies to treat patients with rare cancers.”
The FDA previously had approved Tibsovo for certain adults with newly-diagnosed Acute Myeloid Leukemia or AML, relapsed or refractory AML and locally advanced or metastatic cholangiocarcinoma.
The Abbott RealTime IDH1 Assay was also approved earlier as a companion diagnostic to identify AML patients with an IDH1 mutation for treatment with Tibsovo or Rezlidhia (olutasidenib).
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