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Novartis has announced that the novel investigational treatment asciminib, specifically targeting the ABL myristoyl pocket (STAMP), has been awarded Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA).
Novartis announced that, at primary analysis, the Phase III ASCEMBL study met its primary endpoint of statistically significant superiority in major molecular response (MMR) rate at 24 weeks for asciminib (ABL001) vs. bosutinib.
Novartis' Phase III ASCEMBL study has met its primary goal showing that asciminib was superior to bosutinib in inducing a major molecular response (MMR) in patients with a certain from of chronic myeloid leukaemia (CML).