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The FDA has approved a combination of decitabine and cedazuridine tablets (Inqovi, Taiho Oncology) with venetoclax (Venclexta, AbbVie and Genentech) for patients with newly diagnosed acute myeloid leukemia (AML) who are aged 75 years or older.
The all-oral treatment combination of Inqovi with venetoclax was also approved for adults with AML who can’t tolerate intensive induction chemotherapy due to comorbidities, according to an FDA press release.
Inqovi was previously approved for the treatment of myelodysplastic syndromes and chronic myelomonocytic leukemia.
The new approval, which followed orphan drug designation for decitabine and cedazuridine for this indication, was based on the complete remission rate and duration of remission observed in the single-arm, open-label ASTX727-07 trial. Of 101 patients enrolled, 42 (41.6%) achieved complete remission within a median of 2 months. The median duration of complete remission was not reached.
The recommended dose of decitabine and cedazuridine is one tablet containing 35 mg and 100 mg of each, respectively, given with venetoclax once daily on days 1-5 of each 28-day cycle until disease progression or unacceptable toxicity.
Complete prescribing information, which will be posted on Drugs@FDA, includes warnings and precautions for myelosuppression and embryo-fetal toxicity.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDEdge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter
