Global healthcare major AbbVie has announced that the U.S. Food and Drug Administration (FDA) has approved a combination treatment of VENCLEXTA (venetoclax) and acalabrutinib for previously untreated adults with chronic lymphocytic leukemia (CLL). 

 

The approval, based on results from the Phase 3 AMPLIFY trial, marks the first all-oral, fixed-duration regimen for first-line CLL therapy.

 

“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.”

 

The approval gives patients the potential for time off treatment and introduces a targeted therapy combining two oral medications, updating the first-line standard of care for this common adult leukemia.

 

“With the FDA approval of the combination of venetoclax and acalabrutinib for use as a front-line therapy in CLL, patients in the USA now have an all oral, time-limited option that can be important for many in choosing their treatment,” said Dr. Brian Koffman, co-founder and chief medical officer emeritus, CLL Society. “CLL Society is pleased to see the number of choices available for patients growing.”

 

The AMPLIFY trial, sponsored by AstraZeneca, compared VENCLEXTA plus acalabrutinib against standard chemoimmunotherapy (FCR or BR) in previously untreated CLL patients without del or TP53 mutations. 

 

Administered over 14 cycles, the VENCLEXTA-acalabrutinib regimen reduced the risk of disease progression or death by 35% versus chemoimmunotherapy, with median progression-free survival not reached versus 47.6 months for chemoimmunotherapy.