Novartis' STAMP Inhibitor Under FDA Review For Myeloid Leukemia

by Vandana Singh, Benzinga Editor

August 25, 2021 7:27 AM | 1 min read |

The FDA has accepted for review Novartis AG's 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.