FDA grants breakthrough therapy designation to asciminib for CML
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The FDA granted breakthrough therapy designation to asciminib for treatment of certain patients with chronic myeloid leukemia.
The designation applies to use of the agent for adults with Philadelphia chromosome-positive CML in chronic phase who received two or more tyrosine kinase inhibitors.
The agent also received breakthrough therapy designation for treatment of adults with Ph+CML in chronic phase that harbors T315I mutations.
Asciminib (ABL001, Novartis) is an investigational treatment that targets the ABL myristoyl pocket (STAMP).
The FDA based the breakthrough therapy designations on results of two trials — a phase 1 trial that included patients with Ph+CML, some of whom harbored T315I mutations, and the randomized phase 3 ASCEMBL trial, which compared asciminib with bosutinib (Bosulif, Pfizer) for patients with Ph+CML in chronic phase who received two or more tyrosine kinase inhibitors.
As Healio previously reported, results of the ASCEMBL trial showed a higher percentage of patients assigned asciminib achieved major molecular response at 24 weeks (25.5% vs. 13.2%), the study’s primary endpoint.
The FDA previously granted fast track designation to asciminib.
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