Based on the results of the pivotal phase 3 study (ASCEMBL) [13] and the phase 1, dose-finding study (NCT02081378) [14–16], asciminib was approved in 2021 by the US Food and Drug Administration for the treatment of adults with Philadelphia chromosome–positive CML-CP previously treated with ≥2 TKIs and for those with the BCR::ABL1 T315I mutation [17], followed by approval in other countries. The gene discussed is BCR; the disease is chronic myelogenous leukemia, BCR-ABL1 positive.