AbbVie Seeks OK for All-Oral Leukemia Regimen

AbbVie has submitted a supplemental NDA seeking approval for a new, fixed-duration, all-oral combination regimen of Venclexta (venetoclax) and acalabrutinib for previously untreated patients with chronic lymphocytic leukemia (CLL). The submission is based on data from the Phase 3 AMPLIFY trial, which showed that the venetoclax-acalabrutinib combination significantly improved progression-free survival compared to standard chemoimmunotherapy, according to the company. If approved, it would represent the first all-oral, time-limited treatment option for this patient population, which the company says would be a potential shift in the standard of care.

Venclexta is described by AbbVie as a first-in-class BCL-2 inhibitor that works by restoring the natural process of apoptosis in cancer cells. It is jointly developed and marketed by AbbVie and Genentech in the U.S., and by AbbVie outside the U.S.