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Novartis gets USFDA Breakthrough Therapy designations for STAMP inhibitor asciminib to treat chronic myeloid leukemia
Asciminib (ABL001) is an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP).
Basel: Novartis has recently announced that asciminib – a novel investigational treatment specifically targeting the ABL myristoyl pocket (STAMP) – has been granted Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (USFDA) 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).
Asciminib was also granted BTD for the treatment of adult patients with Ph+ CML in CP harboring the T315I mutation.
These FDA designations, which may allow for an expedited development and review of asciminib, were based on:
- The pivotal, Phase III ASCEMBL trial, where asciminib was compared to Bosulif (bosutinib)* in patients with Ph+ CML in CP previously treated with two or more TKIs
- A Phase I trial that included patients with Ph+ CML, some of them harboring the T315I mutation
The FDA previously granted Fast Track designation to asciminib, and Novartis plans for a submission in the first half of 2021 for review under the FDA Oncology Center of Excellence Real-Time Oncology Review program.
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751