What is the generic name?

ASCIMINIB

What is the Trade Name for ASCIMINIB?

SCEMBLIX

What are the Indications for ASCIMINIB?

• 1 INDICATIONS AND USAGE SCEMBLIX is indicated for the treatment of adult patients with: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). This indication is approved under accelerated approval based on major molecular response (MMR) [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Ph+ CML in CP with the T315I mutation. SCEMBLIX is a kinase inhibitor indicated for the treatment of adult patients with: Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP), previously treated with two or more tyrosine kinase inhibitors (TKIs). ( 1 ) This indication is approved under accelerated approval based on major molecular response (MMR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Ph+ CML in CP with the T315I mutation. ( 1 )

References: https://open.fda.gov/