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AbbVie Reports the US FDA’s sNDA Submission of Venclexta + Acalabrutinib for Chronic Lymphocytic Leukemia

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  • The US FDA has received sNDA of Venclexta (venetoclax) & acalabrutinib in previously untreated patients with chronic lymphocytic leukemia (CLL)
  • sNDA was supported by AstraZeneca-sponsored P-III (AMPLIFY) trial assessing Venclexta + acalabrutinib ± Obinutuzumab vs chemoimmunotherapy in previously untreated CLL pts without del(17p) or TP53 mutation
  • Trial showed that Venclexta + acalabrutinib a 35% reduction in the risk of disease progression or death, showing improved PFS vs chemoimmunotherapy; data was presented at ASH 2024

Ref: AbbVie | Image: AbbVie | Press Release

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