FDA Accelerates Review of Asciminib for Patients with Chronic Myeloid Leukemia


This designation could shorten the FDA review period to 8 months compared to the 12 months under Standard Review.

The FDA has granted Priority Review to asciminib (ABL001, Novartis) for the treatment of chronic myeloid leukemia (CML) following its submission under the FDA’s Real-Time Oncology Review program, according to a press release.

This designation could shorten the FDA review period to 8 months compared to the 12 months under Standard Review.

The review was granted based on positive data from the phase 3 ASCEMBL trial in which asciminib was compared to bosutinib in patients with Philadelphia chromosome-positive (Ph-positive) CML in chronic phase (CML-CP) previously treated with 2 or more tyrosine-kinase inhibitors (TKIs). The reviewers also used data from a phase 1 trial that included patients with Ph- positive CML-CP concealing the T315I mutation.

Many patients with CML remain at risk of disease progression despite available treatments. Further, sequential therapy with currently available TKIs can be associated with increased resistance and/or intolerance. Asciminib is in development across multiple treatment lines for CML, according to the press release.

Breakthrough therapy designations were previously granted for asciminib for the treatment of adult patients with Ph-positive CML-CP previously treated with 2 or more TKIs in addition to adult patients with Ph-positive CML-CP with the T315I mutation.


FDA accelerates review of Novartis STAMP inhibitor asciminib (ABL001) for patients with chronic myeloid leukemia (CML). Novartis. August 25, 2021. Accessed August 26, 2021. https://www.novartis.com/news/fda-accelerates-review-novartis-stamp-inhibitor-asciminib-abl001-patients-chronic-myeloid-leukemia-cml

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