Is Rezlidhia (Olutasidenib) on the market?

Rezlidhia (Olutasidenib) was approved for medical use by the U.S. Food and Drug Administration (FDA) in the United States in December 2022. The trade name is Rezlidhia. It is an anti-cancer drug used to treat relapsed or refractory acute myeloid leukemia (AML) in adults. Rezlidhia is a selective and potent isocitrate dehydrogenase-1 (IDH1) inhibitor that is administered orally. It has not yet been approved for marketing in other countries.

IDH1 mutations are common in different types of cancer, such as glioma, acute myeloid leukemia, intrahepatic cholangiocarcinoma, chondrosarcoma, and myelodysplastic syndrome (MDS), and they lead to an increase in 2-hydroxyglutarate (2-HG). Some of the most common IDH1 mutations in patients with acute myeloid leukemia are the R132H and R132C substitutions. By inhibiting mutant IDH1, Rezlidhia reduces 2-HG levels, thereby promoting the restoration of normal cell differentiation and providing therapeutic benefits for IDH1 mutant cancers. Rezlidhia is taken orally twice daily on an empty stomach until disease progression or unacceptable toxicity occurs. Its product label carries a warning box about differentiation syndrome, which can be fatal. Warnings and precautions related to Rezlidhia include hepatotoxicity and gastrointestinal adverse reactions. Common adverse reactions include nausea, fatigue/malaise, arthralgia, constipation, dyspnea, pyrexia, rash, mucositis, and diarrhea.

After Rezlidhia is approved for marketing, there is little information about its price and other related information. Please consult the medical consultant for details.