US pharmaceutical company AbbVie (NYSE:ABBV) announced on Friday that the US Food and Drug Administration (FDA) has approved its supplemental new drug application (sNDA) for the combination regimen of VENCLEXTA (venetoclax) and acalabrutinib for the treatment of previously untreated adult patients with chronic lymphocytic leukaemia (CLL).

The approval is supported by data from the Phase 3 AMPLIFY trial.

According to Abbvie, 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 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.

Svetlana Kobina, AbbVie's vice president, global medical affairs, oncology, said: "This FDA approval marks a significant milestone for AbbVie and, more importantly, for people living with CLL. 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."