The FDA has granted breakthrough therapy designation to asciminib for the treatment of adult patients with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase who have been previously treated with 2 or more tyrosine kinase inhibitors; or who harbor the T315I mutation.
The FDA approved the supplemental new drug application for ponatinib (Iclusig) to treat patients with chronic-phase chronic myeloid leukemia (CML) with resistance or intolerance to at least two prior kinase inhibitors.
Researchers found that long-term treatment-free remission was not impaired by low-dose TKI regimens for patients with chronic myeloid leukemia.