Posted by Michael Wonder on 09 Feb 2021
Novartis receives FDA breakthrough therapy designations for investigational STAMP inhibitor asciminib (ABL001) in chronic myeloid leukaemia
8 February 2021 - Designation in patients with chronic myeloid leukaemia (CML) resistant or intolerant to prior treatments based on positive data from pivotal Phase 3 ASCEMBL trial evaluating asciminib, an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP).
Novartis today announced that asciminib – a novel investigational treatment specifically targeting the ABL myristoyl pocket (STAMP) – has been granted breakthrough therapy designation by the US FDA for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase, previously treated with two or more tyrosine kinase inhibitors.
Asciminib was also granted BTD for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase harbouring the T315I mutation.
