Shots:

• The approval is based on P-III ASCEMBL & P-I study that evaluates Scemblix in patients with Ph+ CML-CP with T315I mutation who had experienced resistance or intolerance to two TKIs
• The P-III ASCEMBL trial showed an MMR rate (25% vs 13%) @24wks. & patients who discontinued treatment due to AEs (7% vs 25%). An additional P-I data in patients with CML with T315I mutation support the US FDA’s approval for 2nd indication in this patient population
• Scemblix is the 1st FDA-approved CML treatment that binds to ABL myristoyl pocket & has received the US FDA's accelerated & full approval for Ph+ CML-CP. The company has initiated regulatory submission for Scemblix in multiple countries globally

Ref: Novartis | Image:  Novartis