FDA grants accelerated approval to asciminib for chronic myeloid leukemia
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The FDA granted accelerated approval to asciminib for the treatment of adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.
Asciminib (Scemblix, Novartis) is a first-in-class inhibitor that targets the ABL myristoyl pocket (STAMP).
The FDA based approval on results of the ASC4First trial.
Researchers randomly assigned 405 patients with newly diagnosed Philadelphia chromosome-positive CML in chronic phase to receive either asciminib or investigator-selected tyrosine kinase inhibitors. TKI options included imatinib, nilotinib, dasatinib or bosutinib (Bosulif, Pfizer).
Major molecular response (MMR) at 48 weeks served as the main efficacy outcome measure.
Researchers reported a higher MMR rate at 48 weeks among patients assigned asciminib (68% vs. 49%; difference, 19%; 95% CI, 10-28).
Subgroup analysis based on TKI received in the comparator arm revealed a higher MMR rate with asciminib than imatinib (69% vs. 40%; difference = 30%; 95% CI, 17-42).
Adverse reactions that occurred among at least 20% of patients included musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain and diarrhea.
Laboratory abnormalities that occurred among at least 40% of patients included decreases in lymphocyte count, leukocyte count, platelet count, neutrophil count and corrected calcium.
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