Back to News
Feb 20, 2026 8:10 AM

FDA Approval For AbbVie/AstraZeneca's Combination Treatment Could Set New Standard For Slow Growing Blood Cancer

On Friday, the U.S. Food and Drug Administration (FDA) approved AbbVie Inc.'s (NYSE:ABBV) combination treatment for chronic lymphocytic leukemia (CLL).

The FDA has approved the combination of Venclexta (venetoclax) and AstraZeneca Plc. 's (NASDAQ:AZN) Calquence (acalabrutinib) as the first all-oral, fixed-duration treatment for previously untreated patients with CLL, a slow-growing blood cancer where the bone marrow produces too many dysfunctional B-lymphocyte white blood cells.

AbbVie and Roche Holdings AG (OTC:RHHBY) are jointly developing Venclexta.

This milestone is significant as it provides patients with a new, targeted option that may allow for time off treatment, enhancing the standard of care.

This approval is particularly relevant as CLL is one of the most common forms of leukemia in adults, and the new regimen is expected to improve patient outcomes.

The FDA approval was based on positive results from the AMPLIFY Phase 3 trial that showed 77% of patients treated with Calquence plus venetoclax were progression-free at three years, versus ...