Introduction
CML, CML-CP
PHILADELPHIA CHROMOSOME, EMA, CHRONIC MYELOID LEUKEMIA, CML, HEMATOLOGICAL MALIGNANCY
Chronic myeloid leukemia (CML) is a rare hematological malignancy of which the Philadelphia chromosome is the pathological hallmark.In this review, we summarize the assessment by the European Medicines Agency (EMA) of an initial request for “orphan drug” designation and marketing authorization for asciminib in patients with Philadelphia ­chromosome-positive CML-CP which have previously been treated with at least 2 TKIs.