AbbVie (ABBV) said Friday that the U.S. Food and Drug Administration has approved a supplemental new drug application for its combination regimen of Venclexta (venetoclax) and acalabrutinib to treat previously untreated adults with chronic lymphocytic leukemia (CLL).
The approval is supported by data from the Phase 3 AMPLIFY trial.
This milestone updates the treatment of CLL in the first-line setting, establishing the Venclexta and acalabrutinib combination as the first and only all-oral, fixed-duration regimen for previously untreated patients, the company said.
The regimen supports current standards of care by offering patients the potential for time off treatment and giving providers a new, targeted option that combines two classes of oral medications for CLL.
“This FDA approval marks a significant milestone for AbbVie and, more importantly, for people living with CLL,” said Svetlana Kobina, vice president, global medical affairs, oncology, AbbVie.
“As the first and only all-oral, fixed-duration combination regimen for previously untreated patients, the Venclexta plus acalabrutinib approval expands choice and flexibility for patients and providers navigating complex treatment decisions in CLL.”