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