Rezlidhia FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 7, 2022.
FDA Approved: Yes (First approved December 1, 2022)
Brand name: Rezlidhia
Generic name: olutasidenib
Dosage form: Capsules
Company: Forma Therapeutics
Treatment for: Acute Myeloid Leukemia
Rezlidhia (olutasidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
- AML is a fast-growing cancer of the bone marrow and blood cells. Mutations cause the myeloblasts to to grow and divide uncontrollably. Mutations in the IDH1 gene can lead to the accumulation of 2-hydroxyglutarate (2-HG) which interferes with the processes by which immature blood cells become mature cells.
- Rezlidhia works to inhibit mutated IDH1 to reduce 2-HG levels and restore normal differentiation of myeloid cells.
- Rezlidhia is taken orally twice daily on an empty stomach, until disease progression or unacceptable toxicity.
- The Rezlidhia product label carries a boxed warning for differentiation syndrome, which can be fatal.
- Warnings and precautions associated with Rezlidhia include hepatotoxicity and gastrointestinal adverse reactions.
- Common adverse reactions include nausea, fatigue/malaise, arthralgia, constipation, dyspnea, pyrexia, rash, mucositis, and diarrhea.
Common laboratory abnormalities include increased aspartate aminotransferase , increased alanine aminotransferase, decreased potassium, decreased sodium, increased alkaline phosphatase, increased creatinine, increased lymphocytes, increased bilirubin, leukocytosis, increased uric acid, increased lipase, and transaminitis.
Development timeline for Rezlidhia
Further information
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