NOVARTIS AG Asciminib was also granted BTD for the treatment of adult patients with Ph+ CML in CP harboring the T315I mutation.
Despite tremendous advances in CML treatment over the past few decades, some of these pre-treated patients struggle to meet treatment goals due to resistance and intolerance18-23.
With few remaining treatment options, patients in later lines of care may be at risk of progression3-9.
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 TKIs1,2
A Phase I trial that included patients with Ph+ CML, some of them harboring the T315I mutation24
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
About asciminib (ABL001)
Asciminib (ABL001) is an investigational treatment specifically targeting the ABL myristoyl pocket (STAMP)11-17. As a STAMP inhibitor, asciminib is being studied in patients with chronic myeloid leukemia (CML) who experience resistance or intolerance to two or more tyrosine-kinase inhibitors (TKIs), and in several clinical trials in hopes of helping patients across multiple treatment lines of CML11-17, 25-32.
About ASCEMBL
ASCEMBL is the first head-to-head clinical trial in chronic myeloid leukemia using a second-generation tyrosine-kinase inhibitor (TKI) as a comparator. As a Phase III, multicenter, open-label, randomized study, ASCEMBL was designed to evaluate superiority in major molecular response rate at 24 weeks of the oral investigational treatment asciminib (ABL001) versus bosutinib in patients with
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About Novartis
Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world.
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