AbbVie Seeks FDA Approval for Fixed-Duration Venclexta-Acalabrutinib Combo in Untreated CLL

AbbVie has submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration seeking approval for a fixed-duration, all-oral combination regimen of venetoclax (Venclexta) and acalabrutinib (Calquence) to treat previously untreated chronic lymphocytic leukemia (CLL). This submission is based on positive results from the phase 3 AMPLIFY trial, which showed that the combination significantly improved progression-free survival compared to standard chemoimmunotherapy, reducing the risk of disease progression or death by 35%. The regimen offers a novel fixed-treatment duration approach, potentially enabling patients to have time off treatment and marking a milestone in frontline CLL care. Real-world data from the NAOS study in Europe further support acalabrutinib's effectiveness and safety, even in older patients with comorbidities. The submission also aligns with AbbVie's broader oncology pipeline expansion strategy, contributing to recent positive investor sentiment and share price gains. Additionally, the AMPLIFY data has already supported European approval of this combination for treatment-naive CLL patients.