Conclusions
Philadelphia chromosome-positive CML-CP
PHILADELPHIA CHROMOSOME-POSITIVE CML, EMA
Based on the review of data on quality, safety, and efficacy, the EMA CHMP concluded by consensus that the risk‐benefit balance of asciminib was favorable for the treatment of adult patients with Philadelphia chromosome-positive CML-CP previously treated with 2 or more TKIs. The marketing authorization holder (MAH) is required to submit standard Periodic Safety Update Reports and an updated Risk Management Plan when necessary. Furthermore, the MAH is required to complete the 4 ongoing Post-Authorization Safety Studies.