After 23 years, imatinib remains the best front-line therapy in CML. Why use accelerated approval in a setting where patients have a life expectancy comparable to the general population?

Asciminib - a novel TKI - in Newly Diagnosed Chronic Myeloid Leukemia.

Here is a thread I posted on X after asciminib was approved by the US FDA under the accelerated pathway.

References:

Below are the links to:

• the X thread

• our recent publication led by Nethra Srinivasan

• the FDA accelerated approval of asciminib

• Bower et al. publication

• FDA accelerated approval documentation

• imatinib first approval

• nested and adjacent subgroups publication led by Sunny Kim

• two papers by Anushka Walia and Vinay Prasad about limitations of molecular milestones and related topics: here and here.