The US Food and Drug Administration (FDA) received the supplemental New Drug Application for venetoclax (VENCLEXTA) and acalabrutinib (Calquence), an all-oral, fixed-duration regimen, for previously untreated chronic lymphocytic leukemia (CLL) patients.
Venetoclax is currently indicated for CLL or small lymphocytic lymphoma (SLL) in combination with other therapies, and acalabrutinib for CLL or mantle cell lymphoma (MCL) after prior treatment.
The submission is based on the Phase 3 AMPLIFY trial, presented at the 2024 American Society of Hematology Annual Meeting & Exposition. The venetoclax-acalabrutinib combination reduced the risk of disease progression or death by 35% compared to standard chemoimmunotherapy (HR 0.65; 95% CI 0.49-0.87; P=0.004), with a 92.8% overall response rate versus 75.2% (P<0.0001). Median progression-free survival was not reached versus 47.6 months for chemoimmunotherapy at 41 months’ follow-up. The regimen showed a low tumor lysis syndrome rate, according to the press release from Abbvie, the manufacturer of venetoclax.
“This FDA submission marks a milestone for CLL treatment with the potential approval for the first oral combination regimen of VENCLEXTA and acalabrutinib for previously untreated patients with chronic blood cancer,” said Svetlana Kobina, MD, vice president, global medical affairs, oncology, AbbVie.
