Home Alzheimer’s Disease FDA Grants Breakthrough Therapy Designation to Asciminib for 2 CML Indications

FDA Grants Breakthrough Therapy Designation to Asciminib for 2 CML Indications

The FDA has granted breakthrough therapy designation (BTD) to the novel investigational first-in-class STAMP inhibitor asciminib (ABL001) for the treatment of adult patients with Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML) in chronic phase who have been previously treated with 2 or more tyrosine kinase inhibitors (TKIs), according to the agent’s developer, Novartis.1

In addition, asciminib was also granted BTD for the treatment of adult patients with chronic phase Ph+ CML harboring the T315I mutation.

These FDA designations were based on the results observed in 2 trials, including the pivotal phase 3 ASCEMBL trial (NCT03106779) and a phase 1 trial which included patients with Ph+ CML, some of whom harbored the T315I mutation. Data from these trials were shared at the 2020 Annual Meeting of the American Society of Hematology (ASH) Annual Meeting and…

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