The US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with acalabrutinib therapy for untreated adult patients with chronic lymphocytic leukemia (CLL).
CLL is a rare cancer of the white blood cells likely caused by a combination of genetic and other unknown factors. Early signs and symptoms include swollen lymph nodes, fatigue, weight loss, fever, night sweats, and/or frequent infections. Over time, CLL may also spread to the lymph nodes and other organs, including the liver, spleen, and lungs.
Venetoclax is a first-in-class therapy that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein, restoring apoptosis processes. The orphan drug is also indicated for the treatment of certain patient populations with small lymphatic lymphoma (SLL) and acute myeloid leukemia (AML). Acalabrutinib is a Bruton tyrosine kinase inhibitor used to treat mantle cell lymphoma, SLLa, and CLL.
The approval is based on data from the phase 3 global, multicenter AMPLIFY clinical trial. The goal of this study is to evaluate venetoclax plus acalabrutinib alone or combined with obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without del(17p) or TP53 mutation.
Results highlighted that the fixed-duration combination regimen of venetoclax plus acalabrutinib was superior to chemoimmunotherapy and also reduced the risk of disease progression or death by 35% versus chemoimmunotherapy. Additionally, median progression-free survival was not reached versus 47.6 months for chemoimmunotherapy.
The safety profile of the combination therapy is consistent with the known safety profiles of the individual treatments. The most common adverse reactions for venetoclax plus acalabrutinib are neutropenia, headache, diarrhea, musculoskeletal pain, and COVID-19. The most common serious adverse events were COVID-19, COVID-19 pneumonia, second primary malignancies, and neutropenia. The incidence of tumor lysis syndrome was 0.3%. No new safety signals were identified.
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To learn more about CLL and other rare cancers, visit https://checkrare.com/diseases/cancers/