Therapeutic Response

BCR::ABL1 status confers therapeutic sensitivity to Asciminib in patients with Chronic Myeloid Leukemia, BCR-ABL1+.

Statements

Source and description
Scemblix (asciminib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to asciminib for the treatment of adult patients with previously treated philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP).
Scemblix (asciminib) [package insert]. FDA. The U.S. Food and Drug Administration granted accelerated approval to asciminib for the treatment of adult patients with newly diagnosed philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). The package insert states that this indication is approved under accelerated approval based on major molecular response rate and that continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).