Benzinga | Aug 25, 2021 07:27AM EDT

Novartis' STAMP Inhibitor Under FDA Review For Myeloid Leukemia

* The FDA has accepted for review Novartis AG's (NYSE:NVS) marketing application seeking approval for asciminib (ABL001) in chronic myeloid leukemia (CML).

* Under Priority Review, the application is based on data from the Phase 3 ASCEMBL trial, where asciminib was compared to Bosulif (bosutinib) in patients with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors.

* Asciminib specifically targets the ABL myristoyl pocket -- also known as a STAMP inhibitor.

* Novartis has previously received Orphan Drug, Fast Track, and two Breakthrough Therapy designations for asciminib.

* Related content: Benzinga's Full FDA Calendar.

* Price Action: NVS shares are down 0.16% at $92.00 during the premarket session on the last check Wednesday.